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Re: Biobonic post# 38105

Saturday, 05/22/2021 9:00:11 AM

Saturday, May 22, 2021 9:00:11 AM

Post# of 44507
@bio

I agree with u, nothing will be sent to Fda before we get the PR.

What would he send to the fda? Not a BLA, that’s for sure. I don’t recall any requirement that “data” is sent to fda before a PR.

There is nothing GK will send to fda before data. I’m positive of this. Furthermore, why does it matter if he does or doesn’t. Has no effect on data

IMO. They will get the full analysis and review it internally over the course of a few days. Then draft a PR that summarizes the data.

Remember, GK said he wouldn’t announce 298. Remember GK said he wouldn’t announce data lock. He is very clever and tricky.

Btw, Geert tweeted again this am

We clearly are not getting data in the next few weeks.

It’s fine. I continue to take advantage of what’s being handed to me
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