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newman2021

02/24/22 5:18 PM

#446668 RE: Maverick0408 #446647

They need about $3M a month to keep their lights on. They are not fiddling with their thumbs sitting and doing nothing. If no TLD/Pub, it means RA approval ahead, imo. Under ORBIS, you can keep the BLAs confidential.
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Horseb4CarT

02/24/22 10:55 PM

#446739 RE: Maverick0408 #446647

Maverick, bogey at 2 o’clock!

I missed the basis of your “not in Q1” expectation, assuming there was some info to base on?
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skitahoe

02/24/22 11:35 PM

#446744 RE: Maverick0408 #446647

Mav,

If we knew that the BLA was submitted, whether to one regulator, or all four, we ought to be trading even higher than if we had the Journal. We'd know with reasonable certainty that in six months or less we'd have an approval. I suspect that it's possible that they'd do it before announcing it, but the BLA's the biggest thing they're doing, nothing is bigger than approvals from the regulators.

I don't know if the company has made a submittal, but if not, we've got to be getting close. It is one thing that they can do without the Journal, TLD, etc. and it's something they've been working on for well over a year. I don't know that they may not be waiting to qualify the FlaskWorks unit first, but if they aren't waiting, it's very possible that the BLA has been filed with at least one of the regulators, and perhaps all four.

Gary