Replies to post #105366 on Biotech Values

[jq1234]

IF TRUE, that largely negates the assertion that FDA would not bother to inspect unless they were nearing approval and the inference of near-term approval.

ANDA is less transparent. For NDA, inspection doesn't imply approval at all. Inspection is done by district/local office, it is part of review process. There are tons of examples of inspection done without approval. For example, Provenge, FDA requested new trial, FDA also inspected DNDN plant prior to CRL, and raised issues of the plant in CRL. However, plant deficiency was NOT the key reason for rejecting Provenge application.

[poorgradstudent]

At least for NDAs, the manufacturing inspection is a mandatory part of the complete FDA review. So I agree with previous comments that the inspection is necessary for a Teva approval but not sufficient.

Also, if I'm not mistaken, Teva has manufacturing facilities as part of their empire. In that respect, it's not really surprising that they've had a successful appraisal of their plant(s).

If anyone wants to focus on a sneaky angle, you could wonder if Teva said "yes, we've been inspected" because their facilities are regularly inspected. But were they inspected pursuant to the enox filing? The only reason I only bring up a silly little thing like this is if Teva is the owner of the manufacturing (rather than going through a contractor), it would seem redundant / wasteful for the FDA to constantly show up at Teva's facility for the company's own filings.

Just some pointless speculation...