This is great. You are criticizing me for using
Post# of 72447
(Total Views: 252)
Posted On: 06/29/2017 12:38:32 PM
This is great. You are criticizing me for using the term "cheap" poc trial, yet I use that to illustrate that they have indeed progressed into mid-stage smartly, inexpensively. In other words I agree with you on that point. I am not trivalizing these - nor implied it. Don't read posts as if everyone is either a pumper or basher. Or every point is meant to scare longs or shorts, for that matter. I welcome the reply, but try to be objective. These are opinions based on MY experience.
Look, propelling any of these candidates past mid-stage, through a phase 3 that will satisfy the NDA and PDUFA, will take about the amount of funding they have available. IPIX seems to agree, as I see it, that a partnership is necessary, that they will land a deal, and that is a linchpin to their strategy.
The B-ABSSSI is anticipated to require $30M. Nobody has seen a phase 3 trial plan for B-UP, OM or for Prurisol. IT'S A GUESS. But IPIX may have CRO cost estimates for these based on preliminary plans for budgeting purposes. IMO any of the phase 3 trials will be costed similarly to the B-ABSSSI. For FDA approval they need to be much larger than the phase 2 trials recently done. These phase 3 trials will need to be double-blind, multiple sites, and US based. They will require deeper CRO data collection and clinical involvement. Prurisol, with oral admin, relatively short dosing, and less expensive clinical exams (bloods, visual evals) would likely pose the least expensive phase 3 of the candidates. Kevetrin the most expensive for reasons already posted.
IPIX expects a partnership prior to that point to accommodate these costs. I expect that will occur (possibly soon). Call me a basher for laying out what I believe is necessary for their (and my) success.
Look, propelling any of these candidates past mid-stage, through a phase 3 that will satisfy the NDA and PDUFA, will take about the amount of funding they have available. IPIX seems to agree, as I see it, that a partnership is necessary, that they will land a deal, and that is a linchpin to their strategy.
The B-ABSSSI is anticipated to require $30M. Nobody has seen a phase 3 trial plan for B-UP, OM or for Prurisol. IT'S A GUESS. But IPIX may have CRO cost estimates for these based on preliminary plans for budgeting purposes. IMO any of the phase 3 trials will be costed similarly to the B-ABSSSI. For FDA approval they need to be much larger than the phase 2 trials recently done. These phase 3 trials will need to be double-blind, multiple sites, and US based. They will require deeper CRO data collection and clinical involvement. Prurisol, with oral admin, relatively short dosing, and less expensive clinical exams (bloods, visual evals) would likely pose the least expensive phase 3 of the candidates. Kevetrin the most expensive for reasons already posted.
IPIX expects a partnership prior to that point to accommodate these costs. I expect that will occur (possibly soon). Call me a basher for laying out what I believe is necessary for their (and my) success.
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