Replies to post #105336 on Biotech Values

[rkrw]

I don't think anyone thinks the plant inspection is a major issue. You can always get a plant up to code.

And yes, MNTA shareholders must be getting nervous :)

[10nisman]

"I can confirm that both facilities have been inspected. Momenta supporters must be getting nervous. --from Teva"

The above statement is what Ms. Chen is saying Teva told her? You asked her Monday night and she called the Company and received a response by today? So Ms. Chen had nothing else going on but to call and ask Teva questions for a non-paying client? Either she's one of the most productive sell-side analysts or I call BS. Odd response from Teva as well, IMHO.

10nis

[DFRAI]

Rockrat
if TEVA plants got inspected - i guess we should assume that their application passed all the tests fda implemented/stated in the citizen petition answer - those 4-5 steps for characterization/sameness. Hence - we should also assume that MNTA technology is no better than TEVA....

never a bride, allways a bridesmaid...was looking forward to 30-40 range by next year, instead we are looking at 10 range if true

[DewDiligence]

The inferences to be drawn from FDA inspection of production facilities are asymmetric: i.e. the lack of FDA inspections implies that approval is not near, but the inspections per se do not imply that approval is near. There have been myriad cases where the FDA inspected an applicant’s plants and ended up not approving the drug in question on the current review cycle.

The Chinese suppliers of the bulk heparin that is used to manufacture both Lovenox and UFH have been inspected by the FDA as part of the fallout from the 2008 contaminated-heparin crisis. Thus, it’s almost certain that Teva’s suppliers of bulk heparin have been inspected by the FDA independently of Teva’s Lovenox ANDA.

Bottom line: If the response you got from the analyst is accurate, it removes one piece of evidence that Teva is not close to approval. It does not however, imply that Teva is close to approval.