@jellroll - My gut feeling is that it won't be an issue with the...

@jellroll - My gut feeling is that it won't be an issue with the sustained release formulation. FDA has approved a long acting form of exenatide before, and all the preclinical work for the optimised version of PT320 has taken place. They're not looking to exceed the previous CMax that its been approved for. It's very unlikely that they'll have an issue with this, but it's possible since they've never taken PT320 to the FDA before.

@TheDerivative - If the FDA had accepted the IND, Invex wouldn't have needed to wait. They would have announced and held a teleconference call soon after. But like everyone, I'm hoping for the best outcome here. One small hope is that reviewing Paradigm's interactions with the FDA, the only Trading Halt they used for their FDA interactions was the one that had it approved: https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02446657-3A580120?access_token=83ff96335c2d45a094df02a206a39ff4

@SSilverstein - Credit to Invex in submitting it without the large fanfare that ASX companies normally provide at time of submitting e.g. https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02357703-3A564234?access_token=83ff96335c2d45a094df02a206a39ff4

My understanding is that we've submitted a large package as part of the IND. The trial design is for primary outcome ICP and secondary as PMD.

The IND forces the FDA to consider the trial and the preclinical package based on safety rather than efficacy. They have 30 days to consider it before the IND is active. If the FDA is concerned, they will ask for a 'Clinical Hold' until Invex clarifies the questions required.

They won't be providing guidance on whether they accept primary outcome of ICP as sufficient for a single pivotal trial in an IND. They have to go through the scientific Type B/C meeting to get this.