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Replies to post #244950 on Biotech Values

Replies to #244950 on Biotech Values

DewDiligence

01/04/23 10:35 AM

#244951 RE: spongepaul #244950

The nitrosamine problem should be fixable, but I have no idea how long it will take to satisfy the FDA.

DewDiligence

01/04/23 3:43 PM

#244955 RE: spongepaul #244950

More detail on PHAT:

https://www.fiercepharma.com/pharma/phathom-works-generate-stability-data-voquezna-its-new-drug-remains-regulatory-limbo

PHAT won’t even be able to launch the combination treatments for H. pylori that the FDA approved in May 2022 (#msg-168739638) until the contamination issue is addressed t the FDA’s satisfaction.