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Re: dmb2 post# 435671

Monday, 01/17/2022 10:03:14 AM

Monday, January 17, 2022 10:03:14 AM

Post# of 732486
Doingmybest, good to hear from you...and your on the money posts! I, and other posters have argued over the years, that you don't need full manufacturing capacity to get regulatory approval but do need to show a plan for manufacturing expansion. Regarding

I think it is very doubtful they have submitted their BLA already, but, there very well could be some surprises here and they could have withheld communication on such an event if they are involved with new regulatory processes which they can state require confidentiality.

Yes, that may be a wild card regarding a stealth BLA but I don't think so. I would need a sign such as getting BTD like many other drugs that went through that pathway but you never know. Anyhows, again, it's good to hear from you.
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