Biotech Values

[DewDiligence]

As mentioned in the prior post, a Major Deficiency letter is very rare because the FDA need not actually reply to a Minor Deficiency letter within 60 days. (Because ANDAs do not have PDUFA fees, there are no penalties against the FDA for missing the 60-day guideline for the time to reply.)

How many cases do you know of where the FDA issued a Major Deficiency letter?