The data today was disappointing, and it does throw into question whether or not this drug is better than the SOC. It's far from dead though. Dr. Missling is going to have to earn every penny of his paycheck to get 2-73 back on track. Potential for this drug is broad, so he and his team have to focus and come up with a way to get it to market with and/or without AD. Don't fool yourself - the game has now gotten tougher.
It is surprising that so many people (investors included) misunderstand the AD part of this investment. AVXL 2-73 is not about curing AD and it is not about reversing memory loss. It is about coming up with something that is safe and just a little more effective than what is currently out there. If that means sometimes stopping progression and/or giving a small percentage of people some cognitive reversal while safe that is all that is needed. AD has a terribly deficient SOC today and the market is screaming for something better - even if just a little better.
As for the market - it doesn't matter much. It's a huge market regardless of how effective the drug is again assuming safe. This is a game of moving the needle and not curing a disease. AD has no effective treatment today and so an improvement in SOC is almost as good as a breakthrough cure. Millions will take a safe drug that gives them say a 1 in 3 chance of slowing the disease and say a 1 in 5 chance of getting some memory back. AVXL has a golden opportunity to make it big with a safe solution and a just decent efficacy profile.
Efficacy is not the driver. That's a mistake most people make. The standard of care (SOC) is exceptionally low for AD, and so the FDA will be flexible with a drug that has even a slightly better efficacy than the SOC but with a solid safety profile. For this particular disease, and with a goal to get this drug approved, the safety profile is equally if not more important.
I'll explain this one clearly to you. Smart clinical stage companies want to avoid a placebo arm until phase III because they can. The game with any company like this is to continue to move forward by doing what is needed. Placebo (and double blind) is needed for phase III. However we need to get approval to get to phase III first. Cart before the horse. That's how it works.
They switched the topics for today's poster. Based on the release it was originally supposed to talk about MMSE but they decided to focus on safety. So today was about safety with some sprinkling in of efficacy. In my eyes w/respect to efficacy it really doesn't say much which based on the poster title is to be expected. They need to back this up with solid data on Wednesday.
No. While it would be disappointing we have plenty to look forward to here. SOC is incredibly low in this disease so what we already have is better than anything else - and it's all about improving SOC. But let's wait until Wednesday before we make any more assumptions.
I know your MO is to put a negative spin on it. Fact is there is no solid conclusion to draw from this one way or the other because we have Wednesday's data to come. It is just annoying to me that they would do this because it invites questions.
Yes but why include MMSE at all then in this poster?
Mostly yes, what I don't like it that they reiterated 5-week MMSE improvements and didn't mention anything about 31-week MMSE. They should have either removed the 5-week or included the 31-week because it makes one think that there is no sig improvement on the 31-week data.
chemist - today's poster appeared to be positive. Why though did they highlight 5-week MMSE improvement which we already knew? I was hoping for some documentation on 5 week vs. 31 week improvement. Or is this something we are looking to see in Wednesday's poster?
I happened to have followed that very closely. ARNA was one of three different companies trying to get to market with a diet drug. There had been no new diet drugs for years. All three companies had drugs that showed questionable efficacy. While it was impressive to get the drug approved it was also well understood that the market was going to be choppy at best because the drug was proven to only have limited effectiveness. That and there are so many other ways to lose weight. That is why the stock topped out.
AVXL situation is completely different. If this drug gets to market with the type of profile it is currently showing for AD the stock will explode. Millions are clamouring for an AD drug that can improve their lives as there is nothing else out there.
I think you are pointing out that Adam Feuerstein runs a shady operation. There is no doubt that he colludes with funds/money managers. I still do not know why the SEC hasn't investigated his practices.
Is it true that fake posters (i.e jq_dt, etc.) get paid a quarter dollar per post? I'm just thinking if he hits 100 boards a day and posts 100 times per board he's got $2,500. Sounds like a lot but you can get an algorithm to do something like that.
Well since BIIB is at $250/share with a $55B market cap, $500/share would double that market cap to $110B. $560/share would be even more.
There is not one startup company today that doesn't go through hundreds of variations of how to build a business - including weird and strange things that may you scratch your head. The bottom line is to forget about anything in the past because it is irrelevant. Base your decisions on how you feel about present and future.