TD1 - TALI Digital

[kelvin]

Re: AVX - Avexa Limited

Unfortunately, no reply yet......

Not sure if they are able to reply to such sensitive info, but it was worth a try.

Surely there must be some indication soon as to the progress of the phase III data.

It's been a few years waiting......what's a few more weeks/months.....

 

[Not Rene]

well, with any luck, they are only delaying announcing the data, because they want to buy up before the share price rises.... no, wait a minute, that doesn't sound legal.
i'm just terrified they are gonna run out of money and it will all be for nothing

I wish someone like CSL would look at taking over this company, surely it's not too far out of their area, and they said they were looking at buying something! maybe I should lobby them

 

[bumclouds]

Re: AVX - Avexa Limited

Running out of money would be a terrible shame for all those HIV sufferers who have resistance to pre existing classes of antivirals. Surely the government would throw an extra few pennies at a company which has made so much progress already in such an important study?

And if not the government - perhaps another company would see it as a lucrative investment opportunity. Either way, personally, I don't see the ATC project just stopping due to lack of funds. Doesn't seem right.

And then there's always more capital raising, no?

Is anybody able to cite a microcap biotech like this one stopping midway through its phase III trials due to lack of funding?

 

[Not Rene]

Re: AVX - Avexa Limited

Thank you Bumclouds for your voice of rationality and common sense.
My faith is renewed again. Onwards and upwards!

 

[kelvin]

Re: AVX - Avexa Limited

Got my return phone call today from Avexa from Dr Chick CEO of Avexa and asked some relevant questions.

My first question was when would Avexa release to the market the results from the ATC phase III 24 week process..... The answer was between one to two months because they are currently discussing how to process the information from the trial at the 24 week stage. The discussion is between the company, potential partners and the FDA.

Secondly I asked if they would be requiring another capital raising to get through the current process and the reply was that it depends on the talks with the FDA.

Obviously Dr Chick could not release to me specifics, but I felt encouraged by our conversation.

Unfortunately, I cannot give any more info than that......

 

[jonnycage]

Re: AVX - Avexa Limited

wow kelvin straight to the top! thats great that the big boss returned your call.

hopefully positive times to come

jc

 

[Not Rene]

Re: AVX - Avexa Limited

Nice to know that the top is accessible to lowly investors like ourselves.
Still kind of in the dark though. Today it has dropped below 11 cents.

 

[bumclouds]

Re: AVX - Avexa Limited

I'd say that random dip we experienced towards the end of last week was caused by a mass triggering of people's stop-losses at the 'below 10c' mark..

That's the only explaination I can come up with.. Seems irrational.. But then the market is irrational!

 

[Big_Daz]

Re: AVX - Avexa Limited

Hello everyone

What does the new HIV breakthrough mean for this company?

http://www.news.com.au/heraldsun/story/0,21985,26024837-5005961,00.html

Is this one of the companies that AVX has an agreement with re: findings?

Thanks guys

 

[jonnycage]

Re: AVX - Avexa Limited

i dont reckon that discovery will effect much. all going to come
down to the next announment on these trials as to where we are off to
i think

jc

 

[Bull_Gas]

Re: AVX - Avexa Limited

First time poster...LONG TIME AVX sufferer!

Kelvin...I was under the impression that 24 week phase 3 data was not due until 2Q 2010?? Has this been brought forward?

The only information I have been able to extract from management is that there is an ongoing application to the FDA to have the number of patients in the phase 3 trial reduced. In effect a further acceleration of the process.

After the very disappointing market response to the 16 wk phase 3 data, I fail to see how further data will be any different. The market will only respond when ATC is partnered with a large pharma, and the funding cloud is removed.

We could be in for more waiting yet.

 

[jonnycage]

Re: AVX - Avexa Limited

big amount of volume today, maybe announcement around the corner
that is already out in some fields ??

j c

 

[Not Rene]

Re: AVX - Avexa Limited

They have closed the Phase 3 trial early to evaluate data. Does anyone here know if that is a good thing or a bad thing? Do they have enough data to go forward to the next stage? Does this mean that they have been pressured by possible partners to present what data they have too early? Or is it good because they won't need to continue spending lots of money running the trial?

 

[natpierce]

Re: AVX - Avexa Limited

Not Rene,
Can I suggest you look at the hotcopper forum as there is some informative posts regarding the latest announcement. Cortinaboy is very informed on this stock.

 

[jonnycage]

Re: AVX - Avexa Limited

gday natpierce, wanna share you info here in stead of another site ?

j c


doest seem to be a real clear announcement

 

[Kalvin]

Re: AVX - Avexa Limited

They have closed the Phase 3 trial early to evaluate data. Does anyone here know if that is a good thing or a bad thing? Do they have enough data to go forward to the next stage? Does this mean that they have been pressured by possible partners to present what data they have too early? Or is it good because they won't need to continue spending lots of money running the trial?

Could be either. Clinical Trials may be stopped early because of excess side effects of one drug over another, or because one arm of the trial (i.e one drug or other) is obviously better than the other. As this trial is double-blinded, they would not know if it was the standard treatment or the AVX drug, and would have to stop early.

 

[jonnycage]

Re: AVX - Avexa Limited

so kalvin are you holding ? seems like a big bit of breathing space being allowed until early next year. what to do ..


jc

 

[Kalvin]

Re: AVX - Avexa Limited

No, just slightly interested in this company; the drug could be a real winner, but equally, the product space is fairly crowded. I am too concerned about an orderly exit from these biotechs to get involved. The decision to close the trial, though, is likely not the companies, and will have nothing to do with cost reduction.
cheers,
k

 

[jonnycage]

Re: AVX - Avexa Limited

sounds on the fence with a leaning to not good then ? lol

wait and see, like usual with this one

j c

 

[suhm]

Re: AVX - Avexa Limited

looking at their cash burn, it looked to me like they would need to do another cap raising or licence out ATC without having analysed the data set as originally they were supposed to go until week 96.

For me the decision to halt the trial and analyse the results was a positive and I bought a parcel because of it more pending release of the results/licencing agreements.

They had recruited 160 patients into the trial by Nov 24 and over 300 in screening or dosing, so a fair few more would have joined the trial not long after that. The announcement of terminating the trial at week 24 means the last person to enrol in the trial has reached week 24. Assuming they are testing every 8 or so weeks.

They had week 16 data so I don't know their exact study design but they would have around 150 patients up to week 40 so would also be able to present that as an extended data set. More possibly at week 32.

Even if the results are good the FDA might require a follow up study with a longer endpoint like the original study design but at that point it Avexa should have been able to farm out the costs of that for % of the sales.

As with all biotech shares if the product fails its not going to be pretty, upside is market cap is 70m so the product doesn't need to be a blockbuster to see a major uplift in sp.