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roiresearch

08/24/20 8:31 AM

#320028 RE: roiresearch #320016

+300 SI for a therapeutic showing viral inhibition from a RBL lab

move over bacon here comes sizzlean

What's the FDA gonna say, "no, we are not interested" at the CTAP meeting?

LilyGDog

08/24/20 8:45 AM

#320042 RE: roiresearch #320016

Good observations! SI 300, things are farther a long then I thought. yeehaw!!

Go Leo & IPIX!

Last Paragraph says a lot - he should have broken this up into 2 PRs today

Quote:
Interactions with the Food and Drug Administration, through its Coronavirus Treatment Acceleration Program, are anticipated to begin early September, along with the selection of a Contract Research Organization to implement the Brilacidin for COVID-19 clinical trial.

Lastly, the manufacturing of Brilacidin intravenous (IV) drug product is expected to produce an amount in excess of what is estimated to be required for the Company’s planned Phase 2 clinical trial, allowing for extra IV drug product to support potential additional COVID-19 clinical testing.


They already know the dosing according to this last sentence.

and also

This last part suggest possible compassionate use if there is a 2nd wave IMHO

ROMAD Diver

08/24/20 8:52 AM

#320049 RE: roiresearch #320016

I was thinking the second part about the additional IV solution was preparing for the Ph II to become a Ph II / III. Compassionate Use rules aren’t as friendly as you might think. It would be more advantageous to change the phases. Boy, would that ever cause a boom in price!

FDA info on Emergency Use Authorization:

https://www.fda.gov/media/97321/download#page26