TD1 - TALI Digital

Re: AVX - Avexa Limited

ATC really does seem like a winner. With so much positive and absolutely no negatives (so far) it seems unlikely the trials were stopped early for bad reasons. If no one else comes up with a drug which makes ATC redundant, the only thing I can see going wrong (other than the results having been severely fudged!) is one of the monster drug companies putting in a bid the shareholder's can't say no to, leaving us diluted to nothing. However, to do that they're going to have to put in a big bid, so worst case scenario is still excellent.

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Drug wise perhaps...but company wise...what about shareholder destruction? Or is that dilution?

Ive been a holder of AVX for about 3 years now and haven't seen much in the way of my investment moving forwards. In fact quite the opposite holding a large loss.
I passed on the latest C/R, and the one before that...however did participate in the one BEFORE that (53c or something).

Hopefully they will get this to market, though i doubt I'll ever end up in the black.

Re: AVX - Avexa Limited

Go Nuke said:

Drug wise perhaps...but company wise...what about shareholder destruction? Or is that dilution?

Ive been a holder of AVX for about 3 years now and haven't seen much in the way of my investment moving forwards. In fact quite the opposite holding a large loss.
I passed on the latest C/R, and the one before that...however did participate in the one BEFORE that (53c or something).

Hopefully they will get this to market, though i doubt I'll ever end up in the black.

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Ignoring dilution, if ATC was on the pharmacy shelf tomorrow I think your investment would be looking extremely nice. Of course, exactly what will happen between now and getting ATC to market is a difficult thing to predict. The last two capital raisings would certainly have been good ones to jump in for though, and they haven't really diluted things very much. For the sake of the long-term holders, let's hope there is as little need for further capital raising as possible.

Re: AVX - Avexa Limited

Been an interesting year so far for small biotechs making positive announcements to the market - Avexa is due to release its final Phase-III clinical results for its lead product Apricitabine "ATC", sometime this quarter. I don't have any specifics on when - could be imminent, could be 31 March.

If we entertain the notion that Phase-III ATC results will corroborate the good results from Phase-II, that would be a major plus for the company. (anything less than a parallel with Phase-II would be a major negative).

Given the convulsions that have accompanied other biotechs blowing their trumpets, those who have been watching this stock would be well advised to consider their position ahead of the release of Phase-III - is it worth the risk/reward ("risk/reward" I believe is the technical term for 'punt' ), or not?

Avexa has a slightly more substantial market cap than some of the exploding minnows we've seen recently, ie $130 M compared to say $30 M for ADO prior to its recent eruption, whether that helps stabilise the outcome of Phase-III results remains to be seen.

For good or ill, we're approaching the end-game ...

Re: AVX - Avexa Limited

Well, Avexa released results for their Phase-III trials of their leading drug Apriciabine ("ATC"), today, sort of, and left one feeling somewhat half-pregnant.

Results are basically good, in that ATC continues to show a clinical advantage over the control treatment, the long-established 3TC ...

But ... also rather confusing and underwhelming, in that results as published are for a sub-set of the whole Phase-III patient pool, and omit some vital data, such as giving comprehensive figures for 'undetectable' copies of HIV per m/l.

Results for Phase-II were given for patients with less than 50 copies HIV per m/l, and less than 400 copies per m/l.

Published Phase-III only cites figures for patients with less than 50 copies per m/l.

In other words, comparing Phase-III results thus far with the earlier (and highly promising) Phase-II is a bit like comparing apples to oranges.

Mr Market didn't exactly love it to death - opening price of $0.155 fell to $0.145. (with after-the-bell auction yet to finish).

After the brief trading suspension when the announcement was made, trading resumed at $0.175, rose briefly and then gradually fell back.
(Though it should be noted it was a red day for the ASX as a whole).

More detailed study of Phase-III to follow later in this 1st Qtr 2010.

Bit of a damp squib, really - in some ways I would have preferred a crash and burn - at least I'd know where I stood.

But (he said, smiling bravely) ATC stands up as marketable, and now we wonder: is it marketable enough?

Host invited guests into the party, but put on a scratched ABBA record. Crowd restless.

Re: AVX - Avexa Limited

well said mate

really was a whole lot of nothing released, and the marked seemed
to react accordingly

waiting game again

j c

Re: AVX - Avexa Limited

Ahhh, but ABBA went on to great things!!
I am a little confused as to why they would release half of the results though, why did they bother?
I suppose it is nice to get lots of updates though as soon as they become available.

Re: AVX - Avexa Limited

I thought the results were bad, its definitely not a blockbuster drug in its current state, it needed more patients for the trial to be powered appropriately but if the p value was close to .05 big pharma might see it as not inferior to standard treatment and do a deal because it has a better side effect profile.

In its current state Drs would only use it as a salvage drug in multi resistant patients or if pts were intolerant of other medications. It has a niche but for the big money it needs to be much closer to first line treatment than that.

Re: AVX - Avexa Limited

Avexa needs to do its homework regarding a press release to the public and not necesarily to other Biohealth companies after all that is where the Mom and Dad investers are. Beware of its large number of shares and also the large daily volumes with no significant SP movements.

Re: AVX - Avexa Limited

Tibotec have not renewed their option and now we have slumped to 11 cents.
Woe is me :-(
Can anyone see any light at the end of the tunnel now?

Re: AVX - Avexa Limited

Not Rene said:

Tibotec have not renewed their option and now we have slumped to 11 cents.

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Chatter around the traps (read: that other forum) is that Tibotec's disinclination to continue the option for Avexa's 2nd-string, experimental product, Integrase was due largly to corporate trimming at Tibotec (for which some corroboration can be found in a Belgian news report).

Woe is me :-(
Can anyone see any light at the end of the tunnel now?

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Be consoled I feel your woe.
Main game is unchanged: Avexa's primary product ATC is a sound prospect for FDA approval, and commercialisation following on from that. What drives this latest share-price slump is the perception which I well sympathise, that Tibotec's departure from the scene is one more blot on the Avexa copybook.

So I do see light at the end of the tunnel certainly, although the tunnel persists in the annoying habit of tunneling ever further into the unknown.

Things may brighten up, and may perhaps brighten up when unexpected and at any time, so I hold.

P.

Re: AVX - Avexa Limited

here we go again lol trading halt regarding atc - my humble opinion, its
either go or no. too much up in the air - not enough firm info - hope
its good news, but not holding breath

jc

Re: AVX - Avexa Limited

jonnycage said:

here we go again lol trading halt regarding atc - my humble opinion, its
either go or no. too much up in the air - not enough firm info - hope
its good news, but not holding breath

jc

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I've made and lost a lot of money on AVX. I sold out a while ago when the ATC results were announced so vaguely that it seemed they were trying to hide bad news. No p-value? These people are supposed to be scientists, right? If life scientists don't give you a p-value you really need to hold some doubts about how sure they are about things. I had very high hopes for ATC and believed it was going to be a winner, but after the last pieces of news I turned away with no intention of jumping back in. The lack of recent news would have me even more nervous if I was still holding - it's not easy to keep a big deal quiet, but much easier to keep a lack of news quiet.

I agree, it's likely a "go or no" announcement on ATC, which should see either a tremendous loss or something a lot nicer. Way too risky for me and my gut feeling is very negative, but I'm a very interested spectator and look forward to the announcement. For the sake of holders I hope I am wrong, and good luck!

Re: AVX - Avexa Limited

gday mate

some good points, i sold out of half of my holdings with the vague atc update
earlier in the year, and will make the next decision in selling the rest monday.

a shame if its the end

jc

Re: AVX - Avexa Limited

jonnycage said:

gday mate
some good points, i sold out of half of my holdings with the vague atc update
earlier in the year, and will make the next decision in selling the rest monday.

a shame if its the end

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Well, it's the end, alright; to be more precise, the end-game has arrived. I've got no idea what chooks (Chicks?) are coming home to roost Monday, but Monday it is.

Been quite a ride. There may be some reward for the long-suffering, or it may be a debacle. To put it mildly, I'll receive Monday's revelations with interest.

It will be all over on Monday, won't it? I'd go stark-raving barmy if this thing messes with my head with any sort of strung-out saga from here!

(exit left, gibbering)

P.

Re: AVX - Avexa Limited

Well, even though I sold out earlier in the year because I was fairly sure this would happen, I can't help feeling a little disappointed. Not long ago at all I was fairly confident that ATC would be a winner, and it was only earlier this year that I saw it probably wasn't going to be, and today that has been confirmed. Today's price is about what I was expecting, about a 70-75% drop (ouch for those still holding!). If I wasn't already fully committed elsewhere I'd be considering jumping in this morning to profit on the dead cat bounce, but even aside from that, at around 3c they look like good value considering the other projects AVX has on the go. Today might be the best time in a long time to buy. Obviously we are going to see AVX find a completely new place now, obviously far below where it was until very recently, but likely well above where it is in the first few minutes of trade today.

Dare I say, when reports were phrased in a positive but extremely vague way, with p-values etc not given, and in the perspective of what has passed over the last week or so, it looks like the board must have known what was inevitable months ago but were happy to keen investors in the dark. I would have trouble trusting them now (not that you can trust the boards of many companies, of course!).

Re: AVX - Avexa Limited

Sdajii said:

Well, even though I sold out earlier in the year because I was fairly sure this would happen...
.... Today might be the best time in a long time to buy. Obviously we are going to see AVX find a completely new place now, obviously far below where it was until very recently, but likely well above where it is in the first few minutes of trade today.

Dare I say, when reports were phrased in a positive but extremely vague way, with p-values etc not given, and in the perspective of what has passed over the last week or so, it looks like the board must have known what was inevitable months ago but were happy to keen investors in the dark. I would have trouble trusting them now (not that you can trust the boards of many companies, of course!).

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Well said, Sdajii.

I'm hanging on to mine if only because I've written it off as having any value, and a crowded exit throng has no appeal at all.
There's an announcement out as a follow-up indicating a general meeting will be called (no date set as yet) to continue the decapitations, with the Chairman Mr Drona first up for the chop.

Any future for Avexa now depends on who stays - I'll be interested to see if Dr Coates remains as chief medical officer, given that CEO Dr. Chick has walked the plank.

As I said once before, when putting up my hard cash for the various Avexa rights issues, there are worse reasons to lose money than being part of the HIV research story.

I've been part of that story, and I've lost money. I can live with that.

Regards,

P.

Re: AVX - Avexa Limited

General meeting coming up to sort out the mess to some extent
Does anyone have any opinions on which way to vote?

Re: AVX - Avexa Limited

no real opinion on these guys anymore, still holding some, no point giving away just yet. without some kind of revamp of the atc i cant see
much doing

j c

Re: AVX - Avexa Limited

AIDS activists ask AVEXA not to leave patients behind

June 17, 2010

Dr. Susan Cox
Former Senior Vice President, Drug Development at Avexa

Cc: Nathan Drona, Chairman of the Board at Avexa
Stephen Kerr, Board Secretary

We, the undersigned, are asking the decision makers at Avexa to reconsider the decision to stop the development of apricitabine, a nucleoside analog that has shown good efficacy in patients with the most common nucleoside mutation, M184V. Physicians and a growing number of patients with limited treatment options have been counting on the approval of this drug to enable the construction of effective regimens. Apricitabine can mean the tipping point between success and failure of a salvage regimen ? between life and death.

It is well known that the management of multidrug resistant HIV has improved dramatically with the recent approval of a number of highly effective antiretroviral drugs, including raltegravir, maraviroc, darunavir, and etravirine. Despite the impressive effectiveness of these drugs in clinical trials, a growing subset of patients continues to exhibit virologic failure in clinical practice ? even when adherence is good. Most of these treatment failures likely occur because of an inability to construct a regimen containing two to three fully effective agents for individuals with extensive prior exposure to antiretroviral drugs. Some of these patients acquired drug resistance while participating in clinical trials. Failure rates in recent phase III studies such as DUET (etravirine and darunavir), MOTIVATE (maraviroc), and BENCHMRK (raltegravir) were in the 27-40% range. Many of the patients who experienced virologic failure while participating in these studies were subsequently unable to construct suppressive regimens.

The prevalence of multidrug failure in clinical practice is not well documented, however there are signs that the number of patients in need of new options is growing. Deeks and colleagues at UCSF/SFGH have an ongoing observational cohort of patients who have developed drug resistant HIV (the SCOPE cohort). Most of these patients have been able to construct a fully suppressive regimen and are currently doing well. However, of the original 300 patients, approximately 40 now have evidence of having failed all six therapeutic drug classes. These 40 patients have a GSS of either zero or one, and have no clear options for suppressing HIV replication. Many have advanced disease (CD4 < 100) and hence may not be able to wait for the development and approval of multiple new options.

A 2009 survey of 94 responding HIV clinicians in the United States found approximately 250 patients unable to construct a viable regimen due to resistance. In contrast to a common assessment heard in 2009, several key clinicians now recognize that the latest generation of drugs has not proven as durable as they had hoped, and that resistance is slowly reemerging as a problem for some patients. Although the number of multidrug resistant patients with no treatment options may be relatively small, there is concern that this may be the tip of the iceberg and that the industry will not be prepared to meet the need for newer drugs with unique resistance profiles.

The options for constructing a three-active agent regimen for this growing population during the next four years appears to be few, which means that the chances for survival for those with lower CD4 cells counts are diminishing. Consequently, an early expanded access program that makes available current investigational agents that have progressed beyond phase II could help improve the outlook for survival for these patients in need. But the drugs must remain in development.

Other small companies developing new HIV drugs, such as TaiMed and Myriad have faced the same difficulties in finding partners that Avexa has. Of these companies? drugs, though, apricitabine stands out as a member of a well-understood class, the one nearest to approval, and as an agent addressing one of the most common forms of drug resistance among all people with HIV (including those still na?ve to treatment). For the salvage population, convenience in dosing is not the issue: activity is! In our recent meeting with the major HIV drug makers we have been raising awareness about the growing unmet need for new salvage options, and as they hear this message from community and clinicians, they have begun to pay attention. Researchers and statisticians are also working on creative ways to conduct registrational clinical trials in an environment when there are many effective options and a relatively small subject pool (the Forum for Collaborative HIV Research is holding a workshop on this issue in October 2010). Finally, the FDA has said it recognizes the need for new salvage therapies and appears willing to work with companies to bring new products to market in this difficult environment. The tide is turning; this is not the time to abandon apricitabine.

We the undersigned believe that apricitabine is a potentially important drug, and one of the few products currently in the pipeline that could help patients with multidrug resistance tip the balance in favor of viral suppression, health, and, for many, life itself. We ask that Avexa reconsider its decision not only based on potential sales but also on the survival of patients at risk.

Sincerely,
The Members of the AIDS Treatment Activists Coalition- New York, New York
The Members of the European AIDS Treatment Group- Brussels, Belgium

Re: AVX - Avexa Limited

ATTENTION AVEXA SHAREHOLDERS

I just received the Notice from the EGM Shareholders.

An EXCELLENT SUMMARY of what went wrong and of a better way forward for Avexa and its shareholders.

RESTORE VALUE FOR AVX SHAREHOLDERS

to quote... "We strongly believe the decision to close ATC was premature and the reasons given by MR DRONA for its termination to be highly unsatisfactory"

A better way forward...(but why wouldnt this have been done already...

1. Present to the FDA the most recent ATC data and agree with them on a path to market. This is a relatively inexpensive process (so why hasnt it been done MR DRONA)

2. Re-engage partnering discussions with a clear path to market agreed with regulatory agencies

3. Establish an experienced managment team...

4. Provide clearer communication to shareholders...

WHAT YOU CAN DO NOW...

VOTE FOR ALL RESOLUTIONS!