Replies to post #251393 on Innovation Pharmaceuticals Inc (IPIX)

[slcimmuno]

Re the BRI OM EOP2

see (not sure if previously posted... not on IHUB all that much nowadays)

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.47

This is the part that reads most important to my eyes - reach an agreement w FDA, perform to protocol (expectation), and drug should be good-to-go to market.

Do think any pending partnership would await Regulatory clarity before proceeding. Q is how long it’ll take to close any deal/s post a successful EOP2.

Btw ever appreciate your posts PP - esp the chart / data pulls. Good stuff.

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“Agreements reached at the meeting on these matters will be recorded in minutes of the conference that will be taken by FDA in accordance with 10.65 and provided to the sponsor. The minutes along with any other written material provided to the sponsor will serve as a permanent record of any agreements reached. Barring a significant scientific development that requires otherwise, studies conducted in accordance with the agreement shall be presumed to be sufficient in objective and design for the purpose of obtaining marketing approval for the drug.”