Pluristem Therapeutics Inc (PSTI)

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Following your logic below... Should we then expect to wait for ANY FDA Approvals until the Thermo Fisher Partnership results in the ability to 'Make Millions of Doses, In Order to Meet Massive Global Demand." and receiving GMP certificatioin?

Wouldn't that take Thermo Fisher's product being fully GMP approved by the FDA on a time-line of +/- 2-4 years?

https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM407991.pdf


Seems all 'indications' would be serving 1M+ patient populations, and PSTI has already indicated their limited of 'off-the-shelf' internal manufacturing capabilities is 50K doses.


FDApproved
Tuesday, 09/25/18 01:02:19 PM
Re: None
0
Post # of 16027

An FDA Approval Will Never Solve Their Inability To Make Millions Of Doses, In Order To Meet Massive Global Demand. That Is What Is Important Right Now... Hence The Thermo Fisher Partnership ! Do Your Brain Some Good And Learn The Ways Of The Pluristem People.