Grace Therapeutics, Inc GRCE

Healthcare Biotechnology

Grace Therapeutics, Inc., formerly Acasti Pharma Inc., is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Its therapeutic pipeline consists of three clinical-stage drug candidates supported by an intellectual property portfolio of over 40 granted and pending patents in various jurisdictions. Its lead drug candidate, GTX-104, is a clinical-stage, novel, injectable formulation of nimodipine being developed for intravenous (IV) infusion in aneurysmal subarachnoid hemorrhage (aSAH) patients to address significant unmet medical needs. GTX-104 provides a convenient IV delivery of nimodipine in the intensive care unit, eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Its other pipeline drug candidates include GTX-102, which is an oral-mucosal betamethasone spray for the treatment of Ataxia Telangiectasia and GTX-101, which is a topical bio adhesive film-forming bupivacaine spray for Postherpetic Neuralgia.

NDAQ:GRCE - Post by User

Grace Therapeutics, Inc

Bullboard Posts

Post by railbirdon Nov 13, 2018 1:23pm

91 Views

Post# 28966362

Bureaucratic Ineptness ???

Mineral Oil and Placebo Inertness Issue A more detailed review of communications between the FDA and Amarin suggest bureaucratic ineptness and lack of coordination between groups within the FDA, and inappropriate data analysis. Furthermore, the issue never should have been raised, as it had already been dealt with to the satisfaction of the FDA earlier in its review of the MARINE NDA in which a similar observation was noted with the FDA’s review of Lovaza several years earlier.

https://epadruginitiative.com/files/Mineral_Oil_and_Placebo_Inertness_Issue.pdf

Bullboard Posts

Global Tungsten Market and Supply Security