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Wednesday, July 30, 2014 2:27:19 PM
Per Joesph Shan...
Had the study, which was initially reported as demonstrating statistically meaningful overall survival benefits, been confirmed, Peregrine could potentially have sought early approval and sales of the product. This likely would have shaved at least 3 to 4 years from the program and resulted in early commercial sales. While a confirmatory Phase III trial would still need to be done, the FDA,s practices and guidances indicate that it would have required only 300-400 patients in our ensuing Phase III study based on the hazard ratio determined in the Phase II study.
Therefore, there was much more urgency and pressure on AbbVie at that moment in time to ink a deal. Now potential partners have more time to act without missing the boat. Fortunately there is also now a lot of cash on hand to ride them out.
All imo.
The dose switching made AbbVie go on hold, as PPHM PR'ed (without naming names because we know the name from the filings) and when PPHM's investigation was over they had the new info on Bavituximab that made them realise they had something way more powerful then they thought they had.
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