Replies to post #251389 on Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

I concur. You have a point. I based my opinion on the list of topics for EOP2 form this source:
https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM349907.pdf

on page 23 these topics are offered as example for EOP2

- Phase 3 trial design (including dose selection and endpoint selection)
- Adequacy of safety database
- Pediatric studies, including studies required under PREA and Written
Requests issued under the Best Pharmaceuticals for Children Act
- Additional information needed to support NDA/BLA
- Context for SPA submission
- Adequacy of supporting nonclinical data
- Adequacy of supporting clinical pharmacology data
- Adequacy of supporting abuse related data
- Use of data standards for submission

It seems that some reconciliation between your quote and my list is needed. Maybe FDA can give a conditional go ahead to phase 3. Something along the lines: "do these checks first and if no issues arises then you are allowed to start phase 3". Or maybe by expanding phase 3 trial protocol. Otherwise I don't see how one can address, for instance, a finding that current nonclinical data is inadequate. Dunno.

[kfcyahoo]

LR,

In response to your statement " 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."

Regarding the highlighted portion of your above quote, might it be possible they(ipix) request a 3 arm ph 3, rather than a bridging trial(sachets) followed by ph3, meaning they propose the ph3 for B-OM trial be comprised of 3 arms- the 2 arms of 2b(placebo and B swish and spit) as well as a third arm, the sachets?

That's how I would do it(but I'm an engineer in the construction field).

I feel the cartoon, linked below, is more humourous than refereneces of going over Niagra Falls in a barrel, though the latter(the fallas) is likely more accurate to date for ipix investors (at least the buyer got a swing in the end).

http://www.projectcartoon.com/cartoon/46980