Replies to post #113104 on Biotech Values

[pollyvonwog]

I guess the ultimate thing we can take away from this is that MNTA still has sole generic and there is indeed something wrong with TEVA's application.

[jbog]

minor vs major deficiency letter

The key takeaway that I have is that the FDA believes that T-Enox is completely Approvable at this point.

If the FDA thought that T-Enox was NOT approvable they would have issued a major deiciency letter and let Teva answer whatever objections prior to denial.

Teva still has to answer whatever concerns that the FDA has before the drug is approved.

[genisi]

I don't really have a better insight as Teva didn't give the list of questions. My hunch is that Peter, Roy, and Jim will have dinner in a fancy restaurant sooner than I though.