Replies to post #83516 on Innovation Pharmaceuticals Inc (IPIX)

[thefamilyman]

I must disagree with your projected timeline. The QIDP program did not become law until over 6 months after Zerbaxa released topline results. It was a LONG time after that before the FDA had actually established the rules and procedures to enable the legislation. Therefore the QIDP designation had little impact on the timeline and trial design for Zerbaxa. The primary QIDP benefit for Zerbaxa is simply the additional 5 years of IP protection.

I fully expect that Brilacidin's timeline to approval will benefit substantially from the QIDP designation.

What are the expectations concerning the timeline for bringing Brilacidin to market ? If we look at Cubist and the just approved Zerbaxa which btw also got QIDP designation and priority review they published topline results late 2011. 2 pivotal phase 3s and 3 years later they got the FDA approval a couple of days ago.

Now, Cellceutix began patient enrollment for Phase IIb in February and we are now awaiting bottom-line results and a Phase III seems imminent. Obviously, Leo moves very fast but will we need one or two Phase 3s ? And how many patients will be required ? The Phase IIb enrolled 215 patients and I think a pivotal P3 will require at least 4 times that.

So isn't a PDUFA date somewhere late 2017 or Q1 2018 a fairly realistic bet for Brilacidin ABSSSI? - FarmaZutical

On 09 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA, otherwise known as PDUFA V) was signed into law...
...The FDA is required to establish and maintain a list of qualifying pathogens and to adopt final regulations for QIDPs by 09 Jul 2014. There will be a 60 day comment period on the proposed rules, and the rules must be published 30 days before the effective date.

http://www.ask-cato.com/2012/08/fdasia-part-3-generating-antibiotic-incentives-now-gain-and-drug-approval-and-patient-access-changes/

[JTORENCE]

2017, 2018, 2019, If the drugs are successful, CTIX will be long gone before then, courtesy of Big Phara buy out.
Big Pharma does not always wait for PH3 results..