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UNS - Unilife Corporation

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Thanks for clearing that up. I sent off an email yesterday asking UNS elaborate on "final product validation activities" and await their reply.
 
pacestick said:
The validation of an assembly line is standard practice .
Click to expand...
Sorry RSM, I thought it said 'product validation'. Not, assembly line.

I'm getting more and more curious of this company by the minute.
 
LeeTV said:
Still awaiting a reply *sigh*
Click to expand...

yesterday was Sunday I wouldn't expect anyone to be there that is in the office before Monday actually Monday night our time .Your answer would hopefully be in your in box Wednesday morning our time
 
pacestick said:
yesterday was Sunday I wouldn't expect anyone to be there that is in the office before Monday actually Monday night our time .Your answer would hopefully be in your in box Wednesday morning our time
Click to expand...
Yesterday reffered to my initial post. I sent the email off on Thursday 31st March so Wednesday 30th March US time.
 
Unilife Realigns Operations to Drive Sales and Support Commercial Production of Unifill Syringes

Company Expects to Reduce 2011 Expenditures by $12 million

Press Release Source: Unilife Corporation On Tuesday April 5, 2011, 9:00 am EDT
YORK, Pa., April 5, 2011 /PRNewswire/ -- Unilife Corporation ("Unilife" or the "Company") (NASDAQ:UNIS - News) today announced it has commenced a scheduled realignment of its operating infrastructure in preparation for the upcoming full commercial production and sale of its innovative drug delivery devices to healthcare and pharmaceutical customers. This realignment is being led by Unilife's Chief Operating Officer, Dr. Ramin Mojdeh.

The adoption of these business efficiencies is expected to improve Unilife's cash flow and extend cash reserves by over $12 million during calendar year 2011. Through the elimination or deferral of expenditures no longer required at this time, Unilife expects to reduce operating expenses by approximately $5 million during calendar year 2011, and streamline capital spending programs to further improve cash reserves by approximately $7 million during calendar year 2011. These adopted changes will better enable Unilife to efficiently focus cash resources on the production and sale of the Unifill ® prefilled syringe, the Unitract ® 1mL syringe, and the commercialization of other pipeline products.

Over the last two years, Unilife significantly expanded its operational capabilities in order to meet the anticipated production requirements and stringent quality assurance expectations of current and prospective pharmaceutical customers. This operational surge by Unilife included the rapid expansion of its workforce to 150 staff, significant investment in new capital equipment, and the development of a state-of-the-art manufacturing facility in York, PA. As a result of this upfront investment, Unilife has successfully completed all quarterly milestones under the industrialization program for the Unifill syringe since July 2008, culminating in initial production of the product commencing last week, approximately nine months ahead of the original schedule.

Having met this key business milestone, the scheduled realignment now taking place will reduce operational expenditures, better position the Company to initiate the sale of the Unifill syringe to its existing pharmaceutical customer, and help finalize discussions with additional interested parties.

In addition to the elimination of a number of redundant positions across various levels of the organization, Unilife is strengthening and expanding its sales and marketing team to support the more rapid development of commercial relationships with a wider range of healthcare and pharmaceutical companies. A portion of the operational savings will also be redirected to support the continued development of an expanding device portfolio. Unilife expects that as a result of this realignment, it could be in a position to secure development, industrialization or exclusivity agreements with interested pharmaceutical parties that can support the commercialization of some of these pipeline products during the second half of 2011.

Dr. Mojdeh, said, "Having completed the key industrial milestone of initial Unifill syringe production well ahead of schedule, Unilife can implement a planned realignment of its business structure to better service the needs of pharmaceutical customers and deliver value to shareholders. In addition to strengthening our sales and marketing team and increasing our investments in R&D, we are streamlining other areas of our Company to improve cash flow and operational efficiencies. Unilife is uniquely positioned to service the acute needs of pharmaceutical companies that are seeking innovative, customized device solutions for their therapeutic drugs from a full-service partner that is agile, responsive and efficient in its business practices. By introducing these measures, we will accelerate our go-to-market strategy while strengthening our financial profile."
 
Unilife Corporation

Unilife Announces Chairman's Letter to Shareholders


YORK, Pa., April 27, 2011 /PRNewswire/ -- Unilife Corporation ("Unilife" or the "Company") (NASDAQ: UNIS; ASX: UNS) today announced that Mr. Jim Bosnjak OAM, Chairman of Unilife, issued a letter to shareholders as an update on the Company's business.

Dear Shareholder,

As Chairman of Unilife, it is my pleasure to inform you that our Company is rapidly expanding as a commercial manufacturer of innovative drug delivery devices to the pharmaceutical industry. Following the recent completion of several key business milestones, we have begun to advance our position in the pharmaceutical market for prefilled syringes, as well as other fast-growing and highly profitable sectors of the drug delivery device industry.

Initial production of the Unifill ® syringe, the world's only known prefilled syringe with fully integrated safety features, recently commenced at our state-of-the-art facility in York, Pennsylvania. Once final validation is complete in June 2011, we can start filling initial sales orders. A growing number of additional pharmaceutical companies are also awaiting the supply of the Unifill syringe to evaluate its use with their commercial and pipeline drugs, further increasing the potential for growing demand and sales.

The Unifill syringe represents a unique and compelling proposition for pharmaceutical companies. First and foremost, Unifill is a highly differentiated device - a game changer - that sets a new standard for prefilled syringes. Unlike ancillary safety products that are attached onto standard prefilled syringes to comply with needlestick prevention laws, the Unifill syringe is a unique primary drug container that is easy to fill, and can minimize packaging and shipping costs. Its elegant design and enhanced safety features can deliver optimal protection to healthcare workers, reduce healthcare costs, and enhance patient care.

These benefits make the Unifill syringe a powerful choice for pharmaceutical companies seeking to generate brand differentiation in competitive therapeutic classes, and maximize or even extend the lifecycle of their injectable drugs and vaccines. The nearly unlimited pharmaceutical potential of Unifill can translate into several significant commercial opportunities for Unilife. These may include long-term commercial supply agreements, upfront fees in exchange for special rights within competitive therapeutic drug classes, and perhaps even sharing in the revenues of certain drugs that can fully harness the unique nature of our products to help retain or protect market share against branded or generic rivals.

When the Unifill industrialization program began in July 2008, Unilife undertook a significant expansion of its operational capabilities. As a result, we rapidly grew our workforce to 150 staff, completed a 165,000sqf state-of-the-art manufacturing facility within 12 months, and developed the advanced production systems that will enable us to meet projected demand. Due to this large upfront investment in staff, plant and equipment, we have achieved every quarterly milestone under the industrialization program and can commence Unifill sales well ahead of the original schedule. More importantly, we now have the operational capabilities, quality assurance systems and world-class team in place to serve as a strong, reliable and preferred supply partner to pharmaceutical companies.

Unilife is now ready to build long-term commercial relationships with a large network of pharmaceutical and healthcare partners. We have thus realigned and streamlined our organization by eliminating a number of excess legacy positions, while significantly strengthening and broadening our sales and marketing teams and product development capabilities. The core intent of this scheduled and timely restructure is to turbo-charge our business so that we can drive sales of the Unifill syringe and accelerate the commercialization of other exciting products in our pipeline. As an additional benefit, this realignment of our operations will improve our cash flow by $12MM during the 2011 calendar year.

This strategic realignment is also designed to harness the maximum potential of a significant new and emerging opportunity for Unilife. Our streamlined business structure, dynamic team, automated production systems and stringent quality standards position us to progressively emerge as the preferred 'go-to' innovation partner for pharmaceutical companies seeking elegant device solutions that meet the specific needs of their therapeutic drugs and vaccines.

Traditionally, pharmaceutical and biotechnology companies have pinned their hopes on generating at least one blockbuster drug franchise out of dozens of development programs. This is like trying to hit one home run for every 30 or 40 strikes at the ball. It is our understanding that many large pharmaceutical companies are now looking to spread their risk by directing R&D investment towards the development of a greater number of highly personalized therapeutic drugs that can be marketed into smaller patient-specific populations. This new wave of novel drugs and vaccines, such as biologics with a high molecular complexity, will typically need to be matched with equally specialized delivery devices that are custom-designed to meet the specific requirements of the drug, and its effective administration to the patient. Rather than trying to develop such customized devices in-house, pharmaceutical companies are looking to outsource these projects to industry specialists.

What these pharmaceutical and biotechnology companies desire most is an agile, efficient and highly responsive partner that can serve as a one-stop shop for device innovation. Unilife is uniquely positioned to accommodate these unmet pharmaceutical needs. We have a proven track record for the rapid, on-time completion of major projects, and the full-suite of operational capabilities in place to design, develop, manufacture and supply advanced drug delivery devices that meet stringent quality standards. With the commercialization of the Unifill syringe as a unique primary drug container combining integrated safety features with biocompatible materials inside the fluid path, we achieved what many in the industry thought impossible. We can now replicate the success of Unifill on a grand scale to expand our network of pharmaceutical relationships and enter into several new and fast-growing device markets.

I am pleased to state that we have already identified strong interest from several leading pharmaceutical companies seeking to appoint a preferred partner to support them in the convergence of their novel patient-centric drugs with innovative, customized delivery devices. We thus expect to begin entering into agreements with pharmaceutical companies shortly not only for the Unifill syringe and other pipeline products, but additional new devices for complementary therapeutic areas that will greatly expand the size and scope of our industry presence. Moving forward, Unilife is committed to be the preferred partner to pharmaceutical companies in the development, commercialization and supply of novel drug delivery devices across a significant number of therapeutic classes.

We have never been in a stronger position and more confident in our success than we are today. Our future is bright, our potential is great and success is imminent. We thank you for your ongoing support.

Yours sincerely

Jim Bosnjak OAM - Chairman

About Unilife Corporation

Unilife Corporation is a U.S.-based medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes. Primary target customers for Unilife products include pharmaceutical manufacturers, suppliers of medical equipment to healthcare facilities and patients who self-administer prescription medication. These patent-protected syringes incorporate automatic, operator-controlled needle retraction features which are fully integrated within the barrel, and are designed to protect those at risk of needlestick injuries and unsafe injection practices. Unilife is ISO 13485-certified and has FDA-registered medical device manufacturing facilities in Pennsylvania.

This letter contains forward-looking statements. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and on information currently available to our management. Our management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in "Item 1A. Risk Factors" and elsewhere in our Annual Report on Form 10-K and those described from time to time in other reports which we file with the Securities and Exchange Commission.
 
Any sales orders yet?

Did I read correct that the CEO was paid $10m last FY?

That's quite a lot for a company that has yet to sell anything.
 
validation now complete sales contracts about to follow and initial shipments to follow that Shipments should ramp up through 2012 requiring the high speed line to be ordered in the next few months assuming it takes about the same time to build and install as the first one
 
Huh?



Still haven't sold anything that I have read.

Nothing.

 
UNILIFE Stock --- Setting Up For a Short Squeeze ?

Unilife Corporation Meets Their Goals

07.05.2011– The short position in Unilife stock (NASDAQ: UNIS; Stock Twits: $UNIS) has been steadily rising. As of June 15, 2011 there was an aggregate short position 4,728,317 shares in their common stock, up from 1,782,923 on January 14th of this year. Moreover, the rate at which the short position is growing has been accelerating.

This is somewhat counter-intuitive given the fact that the company has either met or exceeded every time line for each of its milestones. In speaking with a few of the analysts who cover the stock, the crux of the short thesis seems to be based on the company’s market cap being $300mm with little revenue to justify it.

The interesting thing about short sellers is that they frequently capitulate when corporate developments materialize that lessen the validity of the stock’s bear story. This can often result in a short squeeze where these bears scramble to cover their short positions driving prices higher. Investors who are positioned long in a stock always know that their downside is to zero. Conversely, bears who are short a stock know that they theoretically have unlimited risk, as a company’s share price can continue to move higher and higher so long as demand outstrips supply.

In the last 52 weeks, UNIS has traded between $3.85 and $6.38. With the stock currently trading at $5.20, UNIS finds itself in the middle of its narrow range. Stocks, by definition, are discounting mechanism of companies’ future cash flows. Despite the fact that Unilife has yet to generate any material revenues they are positioned to do so in a significant way. Furthermore, the company has not only performed according to plan and but has also successfully managed the investment community’s expectations. If anything, they have under promised and over delivered in meeting time lines.

griffin securitiesGriffin Securities maintains a BUY recommendation on UNIS and has a price target of $10.50. In the “investor consideration” section of his June 13 report update he stated:

“Unilife has a market valuation of roughly $280 million, even though its stock lacks fundamental support. That is not surprising in our view, given the unique characteristics of its proprietary technology and its established relations with Sanofi, the largest user of prefilled syringes in the world. Then, too, the implementation of new regulations requiring safety syringes in the European Union in 2013 and the emergence of new biological drugs over the next three years create fertile ground for the Company’s products. Growth-oriented investors should find this scenario to their liking. Just as important, the time is ripe to invest – news about more, novel products and new customers should emerge in the months ahead, and with the initiation of sales, operations should gradually begin to turn profitable.”

See the Griffin Securities report.

unifill

It is worth noting that Unilife CEO, Alan Shortall has made repeated open market purchases of the stock. In his most recent open market purchase which was in March, Shortall invested over $500,000 USD to purchase Unilife stock on the Australian Exchange. The value of his total stake in the company is worth well north of $20 million. Similarly, Dr. Ramin Mojdeh, the Unilife COO who joined the company in January from Becton Dickinson, stepped up to the plate and bought $500,000 worth of stock in the open market in March.

The company has been very vocal about the fact that they are in active discussions with over 20 pharmaceutical companies. Their well-publicized marquis pharma company relationship is with Sanofi-Aventis who has thus far paid $40 million to Unilife in the form of milestone payments. This was echoed yet again in an June 21st interview Shortall did with Jim Cramer on CNBC’s “Mad Money” segment, Shortall indicated that he expects the company to have “announcement after announcement,” referring to new pharma company relationships for their Unifill pre-filled syringe. Here is a recent video produced by Unilife on their "Expanding Opportunities."

Here is an excerpt from Alan Shortall from the quarterly conference call on May 16, 2011.

“We are making great headway with many pharmaceutical and biotechnology companies that have expressed interest in the product. Initial sales of the Unifill syringe to pharmaceutical companies will be used for a range of activities, including the start of two-year drug stability studies, validating the integration of the product into fill-finish lines, and market evaluations. Initial sales of the Unifill syringe during the second half of this year will be at relatively low volumes.

Given that it will take time to progressively build up the capacity of our Unifill production systems to near 100% efficiency, this fits in well with our ramp program. Furthermore, the average unit selling price for these initial small-volume batches will be far higher than what we are projecting for longer-term commercial quantities.”

Let me be clear when I say that our primary goal for the Unifill syringe at present is to get as many drugs onto stability studies as possible. Pharmaceutical companies do not enter into stability studies lightly. It is fair to expect that drugs that go onto stability studies with the Unifill syringe will ultimately lead to the signing of long-term commercial supply agreements.”

Three weeks later on June 7th, Unilife announced that one of its portfolio devices was selected by a leading global pharmaceutical company for clinical trials in conjunction with a pipeline biologic drug for targeted organ delivery. The clinical trial is planned to commence within the fourth quarter of 2011 to the first quarter of 2012.

In the week ending July 1, the stock did in fact trend up to $5.20 from $4.50. Time will tell if this is the beginning of a new move up for the stock.
 
SALES OF PREFILL HAVE BEGUN

<h1 class="newsartsubtitle">Unilife Commences Initial Supply of the Unifill ® Syringe to Sanofi</h1>



YORK, Pa., July 13, 2011 /PRNewswire/ -- Unilife Corporation ("Unilife" or the "Company") (NASDAQ: UNIS; ASX: UNS) today announced it has commenced the initial supply of validated product of the Unifill ® syringe to Sanofi, as per the terms of the industrialization agreement between both parties.

Since signing the Exclusive Agreement in July 2008, Sanofi has paid Unilife a total of approximately $40 million, comprising a $16 million (euro 10 million) fee in exchange for the exclusive right to negotiate the purchase of the Unifill syringe, and to help fund the Industrialization Program for the device up to a maximum of $24 million (euro 17 million). Sanofi has secured exclusivity for the Unifill syringe within the full therapeutic classes of antithrombotic agents and vaccines, plus an additional four smaller sub-groups, until June 30, 2014.

Unilife is now in a position to also commence initial sales of the Unifill syringe to other pharmaceutical companies. Upon the receipt of the Unifill syringe, these pharmaceutical customers will typically conduct drug compatibility and stability studies that will test the device in combination with their injectable drugs. The resulting data is then filed as the last step in completing the regulatory process for the drug-device combination product.

Mr. Alan Shortall, CEO of Unilife, said, "The start of initial sales of the Unifill syringe is arguably the most significant achievement in our company's history. We very much appreciate the support of Sanofi since 2003, when they had the initiative and vision to approach us to develop a new generation of prefilled syringes that can help to improve patient care, while also enhancing and saving the lives of healthcare workers.

"The Unifill syringe is generating strong interest from an increasing number of pharmaceutical companies for use in therapeutic classes outside of those retained by Sanofi. These pharmaceutical companies recognize the significant potential of the Unifill syringe to help generate powerful brand differentiation for their injectable drugs within competitive therapeutic drug classes."

Dr. Ramin Mojdeh, COO of Unilife, said, "The integration of safety features within the glass barrel of a prefilled syringe was a challenge that many within the device and pharmaceutical industries thought to be impossible. Yet, through our operational expertise, core technology platform and innovative spirit, we have successfully overcome a number of technical obstacles to commercialize a game-changing device that is now poised to revolutionize the $2.7 billion market for prefilled syringes.

"The Unifill syringe sits at the leading edge of a rich and diverse platform of advanced drug delivery devices that we are now developing in collaboration with a number of pharmaceutical partners. Having recognized our capacity for device innovation with the Unifill syringe, these top tier pharmaceutical companies are selecting Unilife as their partner to develop other innovative, differentiated and proprietary devices that are customized to address the specific and unmet needs of their biological drugs. These partnerships will enable us to build upon the success of the Unifill syringe and expand our horizons across several additional high-value market sectors for injectable drug delivery devices."

About Unilife Corporation

Unilife Corporation (NASDAQ: UNIS / ASX: UNS) is a U.S. based developer, manufacturer and supplier of advanced drug delivery systems with state-of-the-art facilities in Pennsylvania. Established in 2002, Unilife works with pharmaceutical and biotechnology companies seeking innovative devices for use with their parenteral drugs and vaccines. Unilife has developed a broad, differentiated proprietary portfolio of its own injectable drug delivery products, including the Unifill ® and Unitract ® product lines of safety syringes with automatic, operator controlled needle retraction. Unifill represents the world's first prefilled syringe technology integrating safety within the primary drug container. The products are ideally positioned to help pharmaceutical companies maximize the lifecycle of their injectable drugs and enhance patient care. Unifill syringes, together with other devices that are part of the Unilife technology platform, can either be supplied to pharmaceutical customers ready for use, or customized to address the specific requirements of targeted novel drugs.

For more information on Unilife, please visit www.unilife.com.

This press release contains forward-looking statements. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and on information currently available to our management. Our management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in "Item 1A. Risk Factors" and elsewhere in our Annual Report on Form 10-K and those described from time to time in other reports which we file with the Securities and Exchange Commission.

This follows orders for the unitract at the end of last year and follow up orders for the same

http://ir.unilife.com/releasedetail.cfm?ReleaseID=530400
 
SECOND PHARMA BEGINS PURCHASES OF PREFILL

Unilife Starts Unifill Syringe Sales to Another Pharmaceutical Customer


YORK, Pa., July 19, 2011 /PRNewswire/ -- Unilife Corporation ("Unilife" or the "Company") (NASDAQ: UNIS; ASX: UNS) today announced it has commenced the initial sale of the Unifill ® ready-to-fill syringe to a U.S.-based global pharmaceutical company.

The commencement of Unifill sales to this new customer, whose identity remains confidential at this time, follows the initial shipment of the device to Sanofi last week. Unilife continues to expand its customer pipeline as an increasing number of pharmaceutical companies seek access to Unifill for the delivery of their prefilled injectable drugs.

Unilife expects this new U.S.-based pharmaceutical customer to conduct drug compatibility and stability tests with their injectable drugs in combination with Unifill as per standard industry practices for drug-device combination products. The resulting data is then filed to regulatory agencies as a final step before approval.

Mr. Alan Shortall, CEO of Unilife, said, "Unilife is pleased to have commenced initial sales of the Unifill syringe to another global pharmaceutical company. We expect to continue supplying the Unifill syringe to this customer over the coming months to support their drug compatibility and stability tests with a number of target molecules.

"The Unifill syringe is the world's first and only known prefilled syringe with safety features fully integrated within the glass barrel. The Unifill syringe is essentially a primary drug container, a safety device and a sharps disposal unit all rolled into one. It is strongly positioned to help improve patient care and better protect healthcare workers at risk of contracting infectious diseases, such as HIV via needlestick injuries and other potential transmission modes.

"We are pleased with the strong level of interest in the Unifill syringe from a significant number of pharmaceutical and biotechnology companies that recognize its potential to optimize the lifecycles of their injectable drugs and generate powerful brand differentiation within competitive therapeutic classes. We look forward to entering into agreements with a number of additional pharmaceutical partners over the coming months."

About Unilife Corporation

Unilife Corporation (NASDAQ:UNIS / ASX: UNS) is a U.S. based developer, manufacturer and supplier of advanced drug delivery systems with state-of-the-art facilities in Pennsylvania. Established in 2002, Unilife works with pharmaceutical and biotechnology companies seeking innovative devices for use with their parenteral drugs and vaccines. Unilife has developed a broad, differentiated proprietary portfolio of its own injectable drug delivery products, including the Unifill ® and Unitract ® product lines of safety syringes with automatic, operator controlled needle retraction. Unifill represents the world's first prefilled syringe technology integrating safety within the primary drug container. The products are ideally positioned to help pharmaceutical companies maximize the lifecycle of their injectable drugs and enhance patient care. Unifill syringes, together with other devices that are part of the Unilife technology platform, can either be supplied to pharmaceutical customers ready for use, or customized to address the specific requirements of targeted novel drugs. For more information on Unilife, please visit www.unilife.com.

This press release contains forward-looking statements. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and on information currently available to our management. Our management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in "Item 1A. Risk Factors" and elsewhere in our Annual Report on Form 10-K and those described from time to time in other reports which we file with the Securities and Exchange Commission.

General: UNIS-G

Investor Contacts (US):



Investor Contacts (Australia)


Todd Fromer / Garth Russell


Stuart Fine


Jeff Carter


KCSA Strategic Communications


Carpe DM Inc


Unilife Corporation


P: + 1 212-682-6300


P: + 1 908 469 1788


P: + 61 2 8346 6500




SOURCE Unilife Corporation


Unilife Corporation
250 Cross Farm Road , York, PA 17406
 
Why is it 'confidential' RSM?

And, why do more trials need to be done? It's either FDA approved or not, surely?

 
kennas said:
Why is it 'confidential' RSM?

And, why do more trials need to be done? It's either FDA approved or not, surely?

Click to expand...

The process of getting prefilled syringes to market is long and tedious due to government regulation

stage one
The drug has to be trialled and validated where the pharma has already done this and the drug is currently in use this stage does not have to happen ,There have been many cases where inadequate trial testing have had dissasterous results Thalidimide comes to mind

stage two
The syringe has to be trialed and validated In this it is being tested among other things for deterioration and leakage in a shelf life of two years . This does not have to be done each time a new drug is chosen to go into the syringe

stage three
The drug is put in the syringe and it is again tested to see if there is any adverse reaction . This has to be done for each and every drug that is put into a prefill syringe . In order to prevent such a problem occurring the Unifill RTF syringe is assembled out of materials already used in other RTF syringes However despite this the regulatory authorities still require it to be tested

I dont know about anyone else but I am very happy for them to test as much as they like before they stick it into me

The orders for syringes at this stage from the two pharmas concerned are based on the numbers required to undertake these tests Which have been described by The Unilife CEO as a process not involving risk to further sales . However in order to launch their products when this stage is complete the pharmas will require considerably more syringes . Which is why there will be a ramp up in production throughout 2012

the need for secrecy is interesting and can only be speculated on
 
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