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BooDog

05/02/19 1:34 PM

#261752 RE: PlentyParanoid #261751

Looks to me that they're just about ready to post the protocol for B-OM's Phase III trail. And with that we may see who's going to pave the way financially.


Innovation Pharmaceuticals Receives FDA End-of-Phase 2 Meeting Minutes
https://finance.yahoo.com/news/innovation-pharmaceuticals-receives-fda-end-133000339.html

MXAMDUD

05/02/19 2:00 PM

#261757 RE: PlentyParanoid #261751

FDA website

MinnieM

05/02/19 2:22 PM

#261759 RE: PlentyParanoid #261751

The FDA doesn't appear to publish end of meeting minutes. The meeting minutes along with other information are given directly to the company at some point after the meeting.

At least, that's how I read the last paragraph of this document:

https://www.fda.gov/media/72211/download

The exploratory nature of the analyses and discussions at an EOP2A meeting are intended to result in suggestions and options to assist the sponsor in optimizing the next steps of drug development. Clinical trial simulations and modeling should be shared between the sponsor and FDA staff before the meeting so that the actual meeting focuses on the interpretation and
recommendations for next steps. In addition to the meeting minutes, any additional FDA conducted modeling and simulation materials derived from sponsor-provided data will be given to the sponsor following the meeting. Any further follow-up can be decided at the meeting.







In Reply to 'PlentyParanoid'
Mx, you seems to know a lot. So, please show ignorant me one instance of published FDA EoP2 minutes.