Biotech Values

[DewDiligence]

From the link you posted:

For ANDAs in the year 1 and 2 cohorts, FDA will expedite review of Paragraph IV applications that are submitted on the first day that any valid Paragraph IV application for the drug in question is submitted.

The vagueness of this statement does not instill confidence that P-IV challenges during the year-1 and year-2 cohorts (FY2013 and FY2014) will indeed be reviewed expeditiously. If they are not, then the stated goal for the year-3 cohort (ANDA’s submitted during FY2015) will apply, which is merely that 60% of ANDA’s be reviewed within 15 months.

All told, the stated goals for ANDA reviews in the FDA’s draft document are woefully inadequate, IMO.