Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

"In my opinion second EOP2 would require new information submitted to FDA in response to possible issues pointed out by FDA. In this context new information usually means that some additional lab or trial work needed to be done."

I'm not sure that's the way it works. Here's what I asked:
"2. My recollection is that there will not be a second EOP2 meeting. Is that your understanding?"

I knew at the time that I should have checked my recollection but I got lazy. This is what the question was based on (sorry about the line numbers):
"Requests for Type B and Type B (EOP) meetings will be honored except in unusual
270 circumstances. Generally, with the exception of products granted breakthrough therapy
271 designation status, the FDA will not grant more than one of each of the Type B meetings for
272 each potential application (e.g., IND, NDA, BLA) or combination of closely related products
273 developed by the same requester (e.g., same active ingredient but different dosage forms being
274 developed concurrently), but the FDA can do so when it would be beneficial to hold separate
275 meetings to discuss unrelated issues. For example, it may be appropriate to conduct more than
276 one end-of-phase 2 meeting with different review divisions for concurrent development of a
277 product for unrelated claims or a separate meeting to discuss manufacturing development when
278 the clinical development is on a different timeline."
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM590547.pdf

I don't think that "some additional lab or trial work needed to be done" meets that exception. It seems the statement even anticipates in their e.g. that a change to sachet packaging would be part of the initial meeting. If some kind of bridging trial was needed it sounds like they would make that clear at the original meeting. I get the sense that they would really rather not have a second meeting during that 30 day period, certainly not one that involves the full staff or any broad go/no-go type decisions.


I'm sure you can see what I'm trying to do. It would be nice if we could know in advance that the day after the meeting things were known and not "subject to".


ps. The "with the exception of products granted breakthrough therapy designation status" language wasn't overlooked...it was ignored for the purpose of the question. Why complicate things?