Replies to post #456657 on Anavex Life Sciences Corp (AVXL)

[boi568]

I'd worry more about Miami slipping away than NYC.

[skitahoe]

It's not the FDA's choice, if the company applies to the EU, but not the FDA, the EU will be first.

NWBO choose to file in the UK first, I believe they had a few reasons, mostly tied to production there and substantial compassionate use there so they know more about their vaccine there.

I don't know what advantage the company may believe they have with the EU, but generally I believe they may be faster to act and more likely to approve without conditions. That might convince the FDA to do the same.

I appreciate the advice here and on other sites. The thing about reading all the official filings is that they say what's happened, but not that much about what's planned with the exception of the guidance they're willing to put out. I'll grant you that chat room information isn't necessarily reliable, but some people here often know what the company is considering, that they have good intuition, even if it's not backed by personal information. Certainly some people bash, others pump, I tend to like to ask questions and stir the pot, but I believe there is a lot of good information. In reality all that ultimately really matters is that the company is capable of gaining approvals in time. It may take much longer than people think, just as things like peer reviewed Journals take longer than anticipated for publication. What's important is things planned to happen eventually do. I just hope that after success the company isn't attracted to sell out before earnings build to the point that if sold it's at a price investors feel very good about. This wasn't the case in IMGN's buyout, they asked to soon, well before earnings for their recently approved product, Elahere, built, and they sold for ten times what ABBV, their buyer, thought the drug would be selling annually in the not to distant future. Virtually no value was given to products well into clinical trial that were producing approvable results to date.

If everything but Alzheimer's failed the value of this company would still be a substantial multiple of the current price. I don't expect that, but my point is that success doesn't need each product, or indication it's applied to, to succeed.

Gary

[Steady_T]

I seriously doubt that the FDA cares about which agency approves a drug first.

Just like the EMA didn't seem to be impressed with Aduhelm, the FDA will deal with what is submitted to it when it has the file in front of it to review. If another agency has approved a drug I would suspect that the FDA would see that as a positive. Would that be enough to cause the FDA to approve a drug without a full review of the submittal? I doubt it.

After all, The FDA can't approve a drug that hasn't submitted an NDA.