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Re: boi568 post# 452672

Saturday, 02/24/2024 4:25:44 PM

Saturday, February 24, 2024 4:25:44 PM

Post# of 470246
As a newer investor in the company, I know the company has spoken of a peer reviewed Journal publication. My question is, do the investors here have a feeling for which Journal will publish the article. At NWBO there was a great deal of speculation and I don't believe even one investor thought JAMA Oncology, but that's who published. All were thrilled with it, but most were guessing NEJM, Lancet, etc.

No telling how many Journals a submission is made with, or how many times revisions are required, or how long publication is being held up because some key person isn't available and publication won't happen without that reviewers approval. In NWBO's case it was discussed for many months, probably nearly a year before it happened, but the key is, it happened. I believe the company does get a few days notice, and certain Journals are available on-line before the hard copy is out, but the point is, you never know how long it will take.

At least drug applications are more predictable. I believe that Anavex can justify priority review with all the regulators. In the FDA that means a PDUFA date being established 6 months after they accept the NDA. In the UK, they try to make a decision 5 months after the submission date. I believe the others are all in the 6 month or less range. Nothing is guaranteed, all the regulators can ask for something else, or just move the date, but at least you have a target. If the FDA's approving it may well come at anytime after about 4 months, but denials generally come near or at the PDUFA date.

Gary
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