The EOP2 mtg w/ FDA was mid Dec Minutes received
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Posted On: 03/15/2019 9:08:18 AM
The EOP2 mtg w/ FDA was mid Dec
Minutes received by IPIX re: mtg sometime late Jan or so for IPIX to work on USA P3 submission to FDA
EU branch in Ireland approved in mid Feb
Above time line makes me wonder as to the timing of this PR yesterday. I think IPIX is further along in the process than just getting ready to submit info to EMA. IMO they already have and might even have met w/ the EMA and have the reply from EU as to their requirements since it shouldn't be much different than that received from the FDA as to P3 requirements.
If this is so, talks could be moving very quickly w/ expected partner for OM.
Regarding clown on other site that gave supposed Leo comments, I believe he is pure BS as he said all BPs only interested in cancer drugs and thus only small and midsize BPs interested in Brilacidin. Who really believes any BP would walk away from a possible Humira-type drug in their pipeline?
Could be way off base but my gut just says there is a plan being followed and this PR yesterday/today is part of the rollout.
Minutes received by IPIX re: mtg sometime late Jan or so for IPIX to work on USA P3 submission to FDA
EU branch in Ireland approved in mid Feb
Above time line makes me wonder as to the timing of this PR yesterday. I think IPIX is further along in the process than just getting ready to submit info to EMA. IMO they already have and might even have met w/ the EMA and have the reply from EU as to their requirements since it shouldn't be much different than that received from the FDA as to P3 requirements.
If this is so, talks could be moving very quickly w/ expected partner for OM.
Regarding clown on other site that gave supposed Leo comments, I believe he is pure BS as he said all BPs only interested in cancer drugs and thus only small and midsize BPs interested in Brilacidin. Who really believes any BP would walk away from a possible Humira-type drug in their pipeline?
Could be way off base but my gut just says there is a plan being followed and this PR yesterday/today is part of the rollout.
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