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Re: daemon57 post# 160405

Wednesday, 04/21/2021 10:41:31 AM

Wednesday, April 21, 2021 10:41:31 AM

Post# of 233200
Rahman let it expire and maybe it was why he was let go, but it does not make any difference.

Rolling Review allows a company to submit their BLA in modules but the FDA does not look at each module and give it a thumbs up or down. They don't look at the BLA until it is fully submitted.

So it expires, they resubmit the whole thing when they have all the requisite data.

Until 100% of the BLA is submitted, then it's the same as nothing submitted.

Armchair quarterbacks are up in arms because of a nothing burger.

If you look at the presentation there is information there that is not palatable, in my opinion it was put out to inform shareholders as a requirement for something. This is serving as a kind of a CYA for the company so that a coming event or development is not invalidated by a technicality that shareholders were not fully informed.

Jmho
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