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Poor Man -

01/31/22 8:39 PM

#440131 RE: pgsd #440128

But why?

Is how well TLD is received dependent on this?

I could be wrong but I am still not expecting to see TLD untill after the FDA guidance is formally implemented. Probably looking at 2nd quarter IMO.

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DavidW2

01/31/22 8:45 PM

#440134 RE: pgsd #440128

FDA guidance is formally implemented?? If this is the reason, "Probably" 2 years from today, not "Probably" 2nd Quarter this year. Don't expect FDA acting so fast as you expect.

I don't believe this is the reason for quiet period.
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VikingInvest

01/31/22 9:07 PM

#440139 RE: pgsd #440128

That could be true, but the FDA have sent out soooo many smoke signals that I am not sure it matters at this point.
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danielboog2

01/31/22 9:17 PM

#440140 RE: pgsd #440128

I agree. FDA BLA Pr about April 15, 2022....Followed by TLD, then the Journal whenever!

GLTU
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biosectinvestor

02/01/22 1:16 AM

#440183 RE: pgsd #440128

I agree that it has been a delay, and not sure given FDA journal article it still is practically, but we will have to see. The reality is the guidance was technically not for immediate implementation. But that journal article was unexpected and not sure if a journal would do it. It has been a concern and I think it was more than enough reason, at least up to this point. It might’ve that that plus already implemented rules in the UK might be adequate. Though yours is the more rigorous and reasonable position. Mine is close to wishful thinking.