Replies to post #90211 on Biotech Values

[rkrw]

I enjoyed this line:

<<<Our focus was on the appearance of impropriety>>>

At least this clears the path to put Woodcock on Momenta's bod. :)

[zipjet]

>>Mr. Tyler said such issues "can't handcuff the agency for all time" in reviewing a company's drug application.

Coming from the FDA Chief Counsel, that is an interesting statement. Note "for all time". That seems to admit that the allegation could delay an application.

Given that Janet Woodcock recused herself, any delay should have ended there.

Anyone know when she recused herself?

ij

[mcbio]

Re: MNTA (FDA comments)

FDA Deputy Commissioner Joshua Sharfstein said late Thursday that Momenta's scientists were brought into the Chinese heparin crisis because of their expertise. He said helping the agency address a public-health crisis shouldn't preclude a company from applying for a drug approval. Mr. Tyler said such issues "can't handcuff the agency for all time" in reviewing a company's drug application.

The FDA staff citing its sole use of MNTA for its "expertise" during the heparin crisis strikes me as a fairly bullish sign for MNTA. If FDA staff views MNTA as having expertise, I don't think it's unreasonable to think that MNTA's generic Lovenox is likely being viewed in a better light by the FDA compared to the competition. That just strikes me as pretty obvious.

[DewDiligence]

Amphastar’s response opposing the FDA’s motion to dismiss Amphastar’s lawsuit against the FDA has been filed with the District Court:

Click here (34 pages)

Thanks to mouton29 for making this document available.