End2War who writes:
The only real issues remaining are whether the FDA determines the AVATAR study is strong enough to support a NDA, or if the FDA will advise it needs more evidence for a pivotal study to be considered.
agreed. Doc says the Excellence trial data is needed (if I am not mistaken), and he is best at this perspective on the Board. I think that is the main thrust....which puts the applicaion back into 2023, and initial revenues 8 quarters away from today, give or take, and no meaningful revs from this small indication until 2024, 2 to 2.5 years from now, thinking positively.
Doc328 Friday, 02/04/22 06:10:25 PM
Re: Gator328 post# 349200 0
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349294
of 349381
..... I am not a fan of Missling or the BOD/college buddies.
It's possible Rett parents could exert pressure. I feel Anavex will try to get approval after Excellence but not based on RS001 and Avatar alone...I also feel they will try to get approval for all ages at that point (of course assuming good Excellence results).
Aussie parents of young patients may have more less luck with the FDA than with the TGA - another reason for Missling to add some US sites and get the trial enrolled already. Unlike Duchenne where patients were very eloquent despite their young age, Rett patients can not 'take the stand' to beg for approval.
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While those who post here many times a day, to give themselves and others the play by play ?, we should all pretty much agree that we are investors. The play by play has cost investors who have listened, major losses on this investment. You cannot "talk yourself" into money. The longs here have been wrong and have seen a 600 percent gain evaporate in the last 7 months to a 100% gain (5 to 30 back to 10). Many current owners bought so much higher and have lost serious money, and let's not forget all the dead bodies carted off..who are gone.
So this is not good, this is very bad investors for ssure. With Friends like the play by play guys, who needs enemies. Amateurs get lost in secretarial stuff, Leaders understand big picture.
Doc who is a valuable resource, has lost confidence in Missling, who himself should not be disregarded, and presumably thinks with the redesignation of the Avatar trial, must have a plan for some earlier approval somewhere?
But You yourself End2War, are thinking along the lines of yourself, and Doc...
So the market now is putting this last trial and the sell off to bed now, and imho, which has been the correct one btw, is that the stock now after the drama will trade with the rest of the market in general, and biotech in particular, over the intermediate term....Which means maybe we have hit a bottom in the low 10s,maybe this was an over-reaction caused by Fraudstein, maybe we bounce now, entirely possible or recover,...if biotech is not the place to be, who then knows? Pretender companies like ANVS an alzheimer's company, that went to 125, then back to 30, thought 30 was the bottom, and despite good news, sits at 13 now.
So the question then becomes, what else is going on? RETT will not longer float the boat imho...what else will move the stock? Core strength and undervaluation? It has been an ugly 60 miles of highway the last 7 months. Anybody got any ideas (not saying this summary is correct btw) on the Big Picture?
AI
