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Re: Anshu2 post# 386061

Tuesday, 11/29/2022 11:23:25 AM

Tuesday, November 29, 2022 11:23:25 AM

Post# of 463674
I'm not sure I follow what you're saying. I never stated that Anavex can just submit anything to the FDA willy nilly. I said that data that isn't spectacular should still be sufficient to submit if it shows a semblance of potential for an affected sub-group.

It's up to the FDA to decide whether to approve a drug, but Anavex can submit whatever they'd like whenever they'd like. Dr. Missling has been extremely cautious to time this correctly, to the point where many on this forum wanted him fired for taking too long to submit.

I believe Anavex has data that it believes is good enough to submit to the FDA. On Thursday it will share this data with the world. Whether the FDA decides to accept the submission for review is beyond Dr. Missling's control but the data is ready to go. The only holdup might be if Dr. Missling decides to submit Rett first after the Excellence trial concludes, so as not to interfere with the rare pediatric voucher that is worth up to $100mm.
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