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royalcrushflush

09/03/20 10:03 AM

#322087 RE: roiresearch #322074

In my opinion early means as follows:

Early = 1st to 10th
Mid = 11th to 20th
Late = 21st to 30th
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Lemoncat

09/03/20 10:07 AM

#322091 RE: roiresearch #322074

Just have to be patient. Grant or no grant we should be starting a trial by the end of the year if things line up.

2021 is hopefully going to be an exciting year for IPIX.

COVID phase 2 results.
B-OM deal?
B-UC phase2 trial?
Kevetrin formulation?

Go IPIX!
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loanranger

09/03/20 10:10 AM

#322093 RE: roiresearch #322074

"I will take IPIX's 'early September' comment literally. It did not say first half of September, but rather it said early September (to me meaning sooner than later, but i can always be happy with it meaning before Sept 15th as well)."

Here's the language from the PR:
"Interactions with the Food and Drug Administration, through its Coronavirus Treatment Acceleration Program, are anticipated to begin early September"


Interactions? Not sure what that means. It sounds like the process would begin with the submission of an inquiry by IPIX, the assignment of a review team, a review of the submission and a response to it. Kind of like a SPA submission.

per your link:
https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap-frequently-asked-questions