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biosectinvestor

11/07/21 9:51 AM

#415584 RE: Bright Boy #415580

Your description sounds much more likely accurate to me Bright Boy. Almost any regulatory approval and filing with the federal government that I have even seen, even ones you might not think are anywhere near this complicated, take many months and many thousands of pages of detail and documentation. It is doubtful to me that this would take anything less.

And to do that, requires resources and time typically. Often buyouts are negotiated while this is pending.

It might be that they are way ahead of the curve, which I have never seen before in the context of such a tiny company and even where a somewhat innovative but new drug was being proposed. Not to mention the complexity of external data and this trial. But it is conceivable. I think if they did do that, some we know would act like it was normal and still complain that it was not really timely because x,y and z.
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MI Dendream

11/07/21 10:09 AM

#415587 RE: Bright Boy #415580

I have never launched a me too product, each one has been a new mechanism of action, at least for that disease state. Each one has provided a meaningful benefit to an unmet medical need, although a couple only to a niche group within a population. I work in the US and launch means approval.

Yes, back in my early days of my career, a BLA submission was done with hard copy and it took two semi trucks to transport the package to FDA. It is all electronic now as is the CRF and really the whole Western world. When FDA is motivated by saving lives, they too race to review the package and approve with urgency. Me too products though have to wait until the exact standard PDUFA date and may even be extended at that time.

Two were absolute break-through technologies. One was published in one of the top 3 journals with a corresponding editorial in one of the other top 3 journals calling it the most important medical advance since Dr. Saulk invented vaccines.
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Horseb4CarT

11/07/21 12:40 PM

#415603 RE: Bright Boy #415580

BB

So you’re close with RP or another BP leader of that stature, guessing from the hint you shared.

One of my favorite poems, from Kipling, that comes to mind frequently in my life, seems very apropos to you, Mi Dendream, and especially to Linda Powers (and I’d bet to LL as well,) is IF (link to spoken version, if it works):



Keeping your head when all around aren’t

Being patient when others have lost theirs

Staying honest when subjected to lies

Putting in a full measure of hard work

Being comfortable among common folk & royalty (my favorite I relate to)

Come to think of it, all of us nwbo believers and supporters can relate to this poem especially right now!