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Grace Therapeutics, Inc GRCE

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

Bullboard Posts
Post by hydrocarbsson Apr 04, 2020 10:26am
308 Views
Post# 30878791

How another company handled a failed topline result

How another company handled a failed topline resultSavara had the unfortunate experience of having to present failed trail data.  

They went out and hired:

Savara Appoints Badrul Chowdhury, M.D., Ph.D as Chief Medical Officer


Dr. Chowdhury joins Savara from AstraZeneca, where he was Senior Vice President, Chief Physician-Scientist for Respiratory, Inflammation, and Autoimmunity Late Stage Development, in Biopharmaceuticals R&D. For 16 years prior to that, Dr. Chowdhury served as Director, Division of Pulmonary, Allergy, and Rheumatology Products, Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) where he provided scientific and regulatory oversight of both common and rare diseases such as asthma, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, rheumatoid arthritis, systemic lupus erythromatosis, and various autoimmune and inflammatory diseases


Again:  For 16 years prior to that, Dr. Chowdhury served as Director, Division of Pulmonary, Allergy, and Rheumatology Products, Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA

He presented at this Conference just three weeks later:

December 4, 2019
2:20 PM EST
Evercore ISI 2nd Annual HealthCONx Conference

In that conference he presented detailed trial data that pointed out exactly where the events occurred that caused the trial to fail.

A 16 year FDA stint in his background and he had no problem talking about the trial's details prior to any meeting with the FDA.

Judgement call...

 


Bullboard Posts