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Post# of 701566
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dennisdave

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dennisdave

Re: extrooper post# 627059

Thursday, 08/31/2023 11:23:21 AM

Thursday, August 31, 2023 11:23:21 AM

Post# of 701566
https://finance.yahoo.com/news/outlook-therapeutics-provides-regulatory-fda-100000177.html

the Agency concluded it could not approve the BLA during this review cycle due to several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.



I suggest you email Yahoo and the FDA they are being ridiculous

also tell Thermo that


As I’m sure you heard on the call, the company believes the primary issues are CMC (e.g., manufacturing).

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172724387
Thermo Wednesday, August 30 Outlook Therapeutics board

So its actually you being ridiculous.
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