Innovation Pharmaceuticals Inc (IPIX)

[Whooops]

Thanks BK, here is the wording between the two PR's

From October
"The study documents the ester bond in Prurisol™ (a prodrug) is readily cleaved and converted as expected. This study was requested by the Food and Drug Administration to be included in the Investigational New Drug (“IND”) application with the FDA under a 505(b)(2) designation."

http://cellceutix.com/cellceutix-completes-final-study-to-file-ind-application-for-new-psoriasis-drug-prurisol/

Today
"Because Prurisol is an ester of abacavir, the FDA has requested that Cellceutix conduct a short Phase 1 crossover study to demonstrate that Prurisol converts into abacavir in humans before initiating a larger-scale Phase 2/3 trial."

"IF" they performed the PoC in Europe they would have known this =-)
Good to hear the FDA is more concerned with patients in clinical trials than the EU is..





What all seem to be missing is that for Prurisol to begin trials in January, even a small Phase 1, CTIX must file the INDA before end of December, or sooner. Get ready for the PR announcing the filing of the INDA. Many on this board have been touting that as an expected benchmark and a make or break milestone for end of year share price; well, it's coming, and right soon.

They aren't asking for proof showing Prurisol converts to Abacavir; they are asking to show that as a salt of Abacavir it converts in a similar way. That is why it is a short duration, small study. This is the bridge part of the study, that the much expanded PoC cancelled end of summer, bridging Acabavir processing and elimination to Prurisol's.