Brief: Pharmather Holdings Announces Update Of Type C Meeting With The FDA For Ketarx™ (Ketamine) In Parkinson’S Disease
29/03/2023 12:35
March 29 (Reuters) - Pharmather Holdings Ltd PHRM.CD :
* PHARMATHER HOLDINGS ANNOUNCES UPDATE OF TYPE C MEETING
WITH THE
FDA FOR KETARX™ (KETAMINE) IN PARKINSON’S DISEASE
* PHARMATHER HOLDINGS LTD: FDA SUPPORTED COMPANY'S OVERALL
APPROACH FOR LID-PD PROGRAM
* PHARMATHER HOLDINGS LTD: FDA AGREED THAT WITH APPROPRIATE
DATA,
A NEW DRUG SUBMISSION WOULD BE CONSIDERED UNDER 505(B)(2)
REGULATORY PATHWAY
* PHARMATHER HOLDINGS LTD: FDA ADVISED COMPANY TO MAKE A
FORMAL
SUBMISSION TO BE CONSIDERED FOR FAST TRACK DESIGNATION
* PHARMATHER HOLDINGS LTD: PLANS TO ADAPT ITS PROPOSED
CLINICAL
DEVELOPMENT PROGRAM TO ALIGN WITH FDA'S RECOMMENDATIONS
Source text for Eikon: ID:nGNX2m4y11
Further company coverage: PHRM.CD
((Reuters.Briefs@thomsonreuters.com;))
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