Biotech Values

[DewDiligence]

Yet another CMC screw-up—CLSD -38%:

https://finance.yahoo.com/news/clearside-biomedical-provides-drug-application-110500651.html

In a meeting this week, the FDA’s Office of Pharmaceutical Quality (OPQ) requested that Clearside provide stability data for the triamcinolone acetonide (TA) suspension produced utilizing an enhanced manufacturing process implemented by the Company. The formulation of the TA suspension has not changed; however, OPQ requested the data to verify the comparability of the stability profiles of the batches made with the enhanced manufacturing process with that of the batches originally submitted as part of the NDA.

…As a result of this request, Clearside expects to receive a Complete Response Letter from the FDA on or before its October 19, 2019 PDUFA (Prescription Drug User Fee Act) goal date. The Company plans to re-submit the NDA in the first quarter of 2020 with the requested stability data.