Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

LR, all below are more or less educated guesses.

1. I think that trial size of 200 subjects per trial with 1:1 allocation is sufficient for typical FDA requirement of TWO p3 trials. In any case, Soligenix has not changed their's after getting FDA's approval for P3 in May 2018. I don't expect IPIX getting any special treatment for better or worse on this.

2. Galera ran it's 200 subject p2 trial in about 2 years --> Soligenix time estimate make sense to me.

Worth considering: Soligenix trial has tighter subject rejection filter than IPIX's (and Galera's) forthcoming trials - only cisplatin 100 mg every 3 weeks --> Both IPIX and Galera should have a bit easier time recruiting --> chances for shorter overall trial duration to primary end. Of course, IPIX could be hampered with low funding which equates to low number of sites which equates to longer trial time.

BTW, It looks like Soligenix found funding for it's P3 only after getting FDA approval for P3 (may 2018). Public offering for $8M was priced after that. There are indications of early slow running (= tight funding) in Soligenix's ClinicalTrials.gov filings. For instance, first trial sites (3) registered in January 2018. Maybe we can expect shorter trial times with proper funding. For now that would mean only Galera. We'll see.