Replies to post #258204 on Innovation Pharmaceuticals Inc (IPIX)

[Lemoncat]

The phase 3 is going to be designed with input from both the FDA and EMA. This means if the trial is executed per protocol and satisfactorily meets endpoints (agreed upon by both the FDA and EMA), approval of the drug should be granted by both the FDA (to be sold in the US) and EMA (to be sold in Europe).

Additionally, since we will have clinical sites in both US/EU, it should save a little money on cost since most EU sites will be less expensive for us. That should speed recruitment as well.

I think this is big. I'm guessing some of this is being directed by a potential partner.

[58nout]

FDA/EMA collaborations. This link might help answer your question.
https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-advice-protocol-assistance#parallel-scientific-advice-with-the-food-and-drug-administration-section

[zandant]

And where is the money coming from going forward? That is the pr I would like to see. Without the proper funding, these other press releases are just taking up space.

[petemantx]

One of the biggest cost savers is that since the P3 will be run according to all the specifications of BOTH the FDA and EMA the patients in one P3 can be counted as being in the other P3.

Thus, if 500 patients needed overall, you could have 300 in EU and 200 in USA and the total of 500 satisfies the total requirement of each trial. Cost savings since total patient enrollment for both trials combined is 500, not 1000 as would be needed if P3 didn't meet each regulatory body requirements.

Note that attaining a P3 allowance is usually a milestone. Now that we know we will have a USA/EU P3 that milestone has been met so those monies move over to the upfront payment of the deal.

Such added monies could help Leo dicker a bit further to get a more lucrative IBD deal, use for operational costs, or further pill formulation for IBD and K. Always helps to have some extra cash in the bank.

As to BTD for OM, why has it been declared dead or failed by noteworthy naysayers? Who has any clue if it was ever submitted? Maybe that is something still to be forthcoming as P3 will incorporate both a high dosage and low dosage cisplatin arm and company has designed P3 to achieve even better results in both arms so that BTD could be submitted and received during the P3? Just saying nobody knows for sure, but making declarative statements that it is dead is plain hogwash.