Innovation Pharmaceuticals Inc (IPIX)

[BooDog]

Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.

I'm not sure when the request was made but we do know that we're on track for trial kickoff. As I see it there is no mention of manufacturing (or requirements) in the fast track literature that I've found. But if I remember correctly, manufacturing for both trials (inside US and OCUNUS Has already produced ample brilacidin.

IPIX is ready to rock-N-Roll!!

https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track

Message in reply to:

Fast track also means that manufacturing and distribution has already been worked out, so in that way, yes, there are agreements in place.

I don't think you meant to say manufacturing was a requirement for fast track, I think you meant to say it's already been through that stage for FDA to review their request for fast track review.

And they have, and we were GRANTED!!! Good to go!!!!

January 14, 2021
INNOVATION PHARMACEUTICALS’ BRILACIDIN FOR THE TREATMENT OF COVID-19 RECEIVES FDA FAST TRACK DESIGNATION
http://www.ipharminc.com/press-release/2021/1/14/innovation-pharmaceuticals-brilacidin-for-the-treatment-of-covid-19-receives-fda-fast-track-designation

Message in reply to:

Fast track also means that manufacturing and distribution has already been worked out, so in that way, yes, there are agreements in place.

IPIX CHART LOOKING GOOD!!!