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hankmanhub

01/01/25 11:37 PM

#741460 RE: skitahoe #741458

Pure speculation:
What if they in fact have no need for a BLA, as they may have already signed a buyout deal subject to an approved MAA? (I am not sure I believe this myself!)
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ROS-CH

01/02/25 2:59 AM

#741464 RE: skitahoe #741458

Your take might be correct, but provokes the obvious question :
WHERE do we stand with EDEN ? What do you know and what NOT ?
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martyDg

01/02/25 3:17 AM

#741466 RE: skitahoe #741458

Not pursuing FDA or other regulators due to manufacturing capacity issue is pure speculation.
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iclight

01/02/25 11:45 AM

#741524 RE: skitahoe #741458

NWBO has pumped production expansion for commercialization since 2013. And they pumped 100s of millions of dollars into Cognate to do so, well before they bought Flaskworks for $1.5 mill and stock in 2020. There was never a production capacity issue stopping them from submitting a BLA. Plenty of CDMOs that could handle it. Even ones LP didn’t sell.

And they still haven’t proven Flaskworks can produce an identical product.