The zone of WAG's. I'll take a nibble. But for the moment just for Prurisol. We know the targets...
•Group C (n=27): Prurisol 200 mg bid Outpatient subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy will be recruited to the study. Study participants are required to have a Psoriasis Area and Severity Index (PASI) score ≥ 12, body surface area involvement ≥ 10%, and a static Physician's Global Assessment (sPGA) of moderate or severe (score of 3 or 4).
Primary Outcome Measures ?: 1.Proportion of participants achieving at least a 75% reduction from baseline in PASI score (PASI75) at Week 12 [ Time Frame: 12 Weeks ]
The Psoriasis Area and Severity Index (PASI) quantifies the severity of psoriasis based on lesion severity and the percent of body surface area affected. It is a composite assessment, across body regions, reflected in a single score: 0 (no disease) to 72 (maximal disease).
2.Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 16 Weeks ]
Reporting of Adverse Events measurements, and reporting of adverse events.
There are 9 secondaries but I'll mention 2...
Secondary Outcome Measures ?: 1.Proportion of subjects achieving a static Physician Global Assessment (sPGA) score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline [ Time Frame: 16 Weeks ]
The static Physician Global Assessment reflects an overall severity of the erythema, induration and scaling across all psoriatic lesions on a 5-point scale, where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.
2.PASI75 response at time points through Week 16 [ Time Frame: 16 Weeks ]
The Psoriasis Area and Severity Index (PASI) quantifies the severity of psoriasis based on lesion severity and the percent of body surface area affected. It is a composite assessment, across body regions, reflected in a single score: 0 (no disease) to 72 (maximal disease).
Discussion;
I do agree the strategy has been pass or fail and if it passes it would be an easy sell off with milestones on its future development. The criteria of the trial set the bar to pass imo. The inclusion criteria was pretty intense. I'm thinking the PASI score will be more than achieved. But that's just my own WAG.
Let's not forget (and really the reason for my post) the potential growth for other uses (psoriatic arthritis and rheumatoid Arthritis). Simply, that potential should be included in the milestones.
Sell it off with $30 - $100MM upfront with the milestones that include growth potential (major bucks on that note). The 5052b pathway certainly gets top bidding since it will be much easier to move to market quicker. I see it as a no brainer that it will move forward, but that is just me being optimistic. But yeah, fetching the $Billion$ figure is there.
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