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Post# of 144815
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DragonBear

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DragonBear

Re: oldmusky post# 73438

Saturday, 08/19/2017 2:44:27 PM

Saturday, August 19, 2017 2:44:27 PM

Post# of 144815
Upgraded to a pivotal trial, fast track-wrong

The FDA would need to see the trial protocol in a submitted IND to deem it pivotal. Where's the IND?

The FDA never grants fast track status, until data has been generated by a clinical trial. It comes after a Phase 2 trial has shown dramatic results, with follow on data from a Phase 3 trial. PMCB has no clinical trial data to show to the FDA. Neither have they submitted an IND to be able to start a Phase 1-2 clinical trial.

more patients, more time. Sooner to market. Too easy



After 3 yrs it should be easy to submit an IND. So where is it? Microcrap biotech scams don't go to market-other than share dumping on the OTC market.

The Jewel of the Mind is Colored with the Hue of what it Imagines

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