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Monday, 01/25/2021 10:40:24 AM

Monday, January 25, 2021 10:40:24 AM

Post# of 144814
Is this a real update?

HERE'S A REAL UPDATE:
I wrote to PMCB Investor Relations and they responded.

Questions:

1. Are the requests from the FDA pertaining to the IND Hold, extensive in nature when it comes to Research and Development?
(IR answer: YES).


2. Have some/any of the issues/requests from the FDA been completed or fixed for the future (CT) Clinical Trial?
(IR answer: The requests/issues have been assembled into groups.)


3. Does the FDA limit/restrict how PMCB can (re)submit for CT because of the results of the previous FDA Hold/IND submittal? (for example, forcing PMCB to a lower level CT Phase Study)?
(IR answer: The CT is designed to be a late Phase 2 Study as directed by the FDA in our Pre-IND meeting.


4. Does PMCB have an estimated time frame of completion of the FDA Hold issues/requests?
(IR answer: NO).

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