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Lets hope we get FDA approval.GLTA
$PHRRF News March 3, 2025 - PharmaTher Provides Complete Response Amendment for US FDA New Drug Application for Ketamine https://www.pharmather.com/news/pharmather-provides-complete-response-amendment-for-us-fda-new-drug-application-for-ketamine
$PHRRF -The Company expects to resubmit information to address the deficiencies classified as MINOR in the complete response letter (“CRL”) by January 2025.
https://finance.yahoo.com/news/pharmather-announces-fda-drug-application-130000255.html?soc_src=social-sh&soc_trk=tw&tsrc=twtr
$PHRRF Christmas Special - FDA provided preliminary responses to questions contained in the clarification only post-CRL meeting scheduled for December 2, 2024
PharmaTher has decided to cancel the meeting as the FDA preliminary responses were satisfactory and do not require further discussion
PharmaTher initiated activities to address the MINOR deficiencies cited in the CRL
https://finance.yahoo.com/news/pharmather-announces-fda-drug-application-130000255.html
$PHRRF EMA Analysis
$PHRRF FDA New Drug Application for Ketamine goal date of October 29, 2024.
https://finance.yahoo.com/news/pharmather-announces-fda-drug-application-120000733.html
$PHRRF Pivot indicator looking good here - https://schrts.co/DrQWIMBS
This application is good for Parkinsons Dyskinesia.This could be big because the patient could apply the patch themselves.GLTA
$PHRRF Technical chart
$PHRRF Chart looking good > https://www.centralcharts.com/en/2254353-newscope-cap-corp-phrrf/charts
$PHRRF The Company aims to submit its responses to the FDA by the end of this week. There can be no assurance the GDUFA goal date will be met. Should the goal date not be met, the FDA would provide a Complete Response Letter to the Company to address the responses, provide additional feedback, if any, and assign an appropriate goal date. The Company is prepared to address potential FDA requests and concerns immediately and will update shareholders as they occur.
https://finance.yahoo.com/news/pharmather-provides-priority-original-abbreviated-120000352.html
What???
$PHRRF 80% strong buy opportunity from @Barchart
https://www.barchart.com/stocks/quotes/PHRRF/opinion
Fabio Chianelli, CEO of PharmaTher, commented: “We believe 2024 will be a transformative year for PharmaTher with the expected FDA approval of ketamine having an assigned goal date for approval on April 29, 2024. In anticipation of a potential FDA approval, we are focusing on the commercial scale-up of ketamine in the U.S. and seeking additional international approvals.”
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