Grace Therapeutics, Inc GRCE

Healthcare

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.

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Grace Therapeutics, Inc

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Comment by postie1on Jun 30, 2020 4:44am

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Post# 31206355

RE:RE:RE:T2 FDA Discussions

Isn't the screw up before the trial even started. Is it possible that the FDA is saying you can't change requirements but a lot of people did not fit the requirements to begin with? I am hoping that the FDA wants to see all the data and then take it from there to see what course of action might be required or maybe back to square one all over again. Obvious that Capre works but has to be properly proven. Highly unusual to say the least about what happened.

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