Biotech Values

[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.