Pharmather Holdings Ltd C.PHRM

Quality deficiencies; what does mean??

[topgun]

TORONTO, Feb. 12, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the "Company" or "PharmaTher") (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, provides an update of its Priority Original Abbreviated New Drug Application ("ANDA") for Ketamine that was accepted by the U.S. Food and Drug Administration (the "FDA") and assigned a Generic Drug User Fee Amendments of 2022 ("GDUFA") goal date of April 29, 2024. The ANDA continues to be under review by the FDA and has provided preliminary thoughts on possible deficiencies identified by Quality. The Company aims to respond to satisfy the preliminary thoughts on possible deficiencies before the goal date. The Company received a waiver from the FDA for bioequivalence studies and has not identified any deficiencies. There can be no assurance the goal date will be met. The FDA may assign an appropriate goal date. The Company will provide updates as they occur.

[TheLandedEagles]

Ya...they said "Thoughts of Possible deficiencies"...good question. What the hell does that mean!!!. Maybe nothing, and involves a simply reply by CEO....Who knows..doesn't sound that serious..as they put it.