Replies to post #248490 on Innovation Pharmaceuticals Inc (IPIX)

[DaubersUP]

I questioned that as well to IPIX with no response. I do know that Private companies are sometimes quicker on all fronts....less hoops with SEC and more funding in other areas.

I am in the camp that we applied and were asked for more info this summer after final data was out. I think they reapplied in Sept sometime.

I recently communicated with Ipix about this subject and they are tight lipped.

[kfcyahoo]

"What’s up with Galera Pharmaceuticals getting BTD on “GC 4419” for treatment on OM in February 2018? Doesn’t that help us , the idea OM needs an expedited remedy?"

Q1: Galera recruiting in ph 3(335 patients). Start date Oct 2018, estimated primary completion date Oct 2020, estimated primary completion 2024.

https://clinicaltrials.gov/ct2/show/NCT03689712?term=galera&rank=7

Q2: You would think that would help ipix. Not everyone operates with the same efficiency. It does take some people a little longer to get things done.

idk

[loanranger]

A breakthrough therapy is a drug:
-intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition and
-preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
https://www.fda.gov/regulatoryinformation/lawsenforcedbyfda/significantamendmentstothefdcact/fdasia/ucm329491.htm

What we learned from the Galera grant is that OM meets the "serious or life threatening disease or condition" standard.

If the IPIX submission falls short its due to something the FDA doesn't like about the preliminary clinical evidence qualifications.