Biotech Values

[DewDiligence]

For ANDAs, one of the determinants of whether the FDA issues a Major Deficiency letter or a Minor Deficiency letter is how much time the FDA itself thinks it will need to reply when the applicant answers the FDA’s questions and resubmits. Because ANDAs do not have PDUFA dates, the 180-day and 60-day periods for the FDA to reply to a major or minor deficiency, respectively, are merely guidelines rather than requirements. In practice, therefore, the FDA rarely issues a Major Deficiency letter.

I would respectfully disagree with the posters who think today’s news implies that Teva is close to getting FDA approval in terms of either timing or difficulty.