Wow, the Lancet is about as prestigious as it gets in the world of academic journals!
conference presentation, not a journal publication
LOL at you trying to dictate the terms of the conference presentation and how it's interpreted. Why don't you just run for the hills right now? The way you framed your post makes it clear you're already chomping at the bit to do so.
Anavex would not have attracted such a distinguished Scientific Advisory Board if it was a "smoke and mirrors" operation.
I disagree, but it's a matter of semantics not worth pursuing. I read your transcript of the Neuronetrix guy's email elsewhere -- very cool, thanks for sharing that.
I will say, on second thought, that his email (at least what I saw from your transcript of it) does_not_ state that the trial was not powered to measure statistical significance (though he did say stat sig would not be "expected" from 12 when the target number is 32). Missling in the presentation today said that 32 patients puts them in the "sweet spot" of what they need to know as far as efficacy. I think that 10 of 12 back in July already told them that the trial would be a success (as even 10 of 32 doing 4x better than on donepezil alone would be a good outcome that would justify moving into phase 2b/3).
Good Lord. There are no healthy patients in the trial. Inclusion requires "diagnosis of Probable AD in accordance with NINCDS-ADRDA criteria" and "a brain CT or MRI scan...consistent with the clinical diagnosis," as well as residence in a "community dwelling with caregiver."
Anavex is interested in the preventative as well as the therapeutic potential of 2-73. That's why Hampel joined the Scientific Advisory Board -- he is a world authority on "early detection...before the onset of any clinical signs and symptoms."
Do you think a drug that could help prevent patients diagnosed with Probable Alzheimer's (but still possessed of good cognitive function from 25-28 MMSE) from progressing further into the disease, or even reverse the diagnosis, might create some demand in a market where it can do that 4x better than donepezil?
The question is rhetorical.
Right, and patients in the trial with MMSE scores from 25-28 must also have a clinical diagnosis of Probable Alzheimer's, a brain scan that supports that diagnosis, and dwell in a community-living facility with a caregiver.
Wouldn't you rather start taking Anavex 2-73 when your early-detected Alzheimer's diagnosis has not yet badly impaired your cognition (MMSE 25-28 out of 30) versus taking it when you're already heading downhill fast (MMSE 16-18)?
well, based on the preclinical and clinical results so far, as well as the scientific theory behind the testing, it's a fact that it "may be able" to do that
Trending with the market? Hardly. AVXL stood pat while the rest of the biotech world went down in flames the past two weeks.
No, he's not. There is a conference presentation on Nov 7th in Barcelona where they will report MMSE and other data -- initial title of the presentation (since revised) included the words "clinical cognitive improvement observed"
When you refer to phase 2b, I think you really mean Part B of phase 2a (the 6/12 month extension of the 36-day Part A), correct? After the 6/12 month extension, concluding in 3Q 2016, AVXL will either do a phase 2b trial or, if the FDA gives 2-73 an accelerated review, a phase 3 (perhaps while making the drug fully available if it performs impressively enough in phase 2a).
No, phase 2b and phase 3 are separate. It is possible that if 2-73 shows outstanding efficacy in phase 2a that the FDA could allow the company to skip phase 2b and go straight into a phase 3 trial.
INO won't be a loser for long -- totally illogical that it's gone down so much
Hey seriallong, that is my understanding, yes. If final Part B (of phase 2a) data can replicate preclinical and interim-phase-2a levels of efficacy, I think we'll see your second scenario. It's even possible that phase 3 and commercialization could happen simultaneously if the FDA is sufficiently impressed by the breakthrough character of 2-73.