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Re: Fireman02360 post# 134426

Friday, 12/15/2017 8:41:59 AM

Friday, December 15, 2017 8:41:59 AM

Post# of 519015
Morning FM,

Hope you don’t mind if I throw a few thoughts in on this matter even though it wasn’t addressed to me.

PS. Could you give us your thoughts about the PD trial now taking place in Europe? Some here speculate the FDA did not think Anavex has enough resources to run 2 trials concurrent to each other.



First off (and I’m pretty dang confident on this), but I don’t believe that companies are required to submit a financial report along with their IND submissions. They go to the FDA with evidence about their drugs not their corporate structure or financial wherewithal. Technically one or two people at a company could contract through CRO’s to run whatever size trial (or even multiple trials) were necessary so I doubt that would be a reason for the FDA to deny Anavex’s request to run multiple trials either.

If we were to assume that the speculation you referenced was indeed correct, are folks ready to claim that the Alzheimer’s trial cannot start in the U.S. until the Rett trial is completed because of that same FDA concern? I doubt it.

Not sure how much time you have to look but there are a variety of reasons to consider the EU instead of the US.

http://www.sciencedirect.com/science/article/pii/S2452302X16300638

Glad to see that since you are new to biotech that your remembering your L.O. about not being familiar with local weather conditions.

Cheers and Happy Holidays to you and yours.

Looking forward to seeing Mycroft’s response as well.
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