Very objective article.
I will add:
<<If we put together all that has been said up to this point by everybody, including the firm’s management and Dr. Waksal himself, we develop the impression that the problem is about the company’s failure to provide documentation on the "refractory" nature of patients enrolled in the trial. The word nature is still subject to various interpretations, the most optimistic would be that the firm has, indeed, proven that the patients were refractory to chemotherapy, yet, some required details were still missing. Another possibility suggested by some analysts is that, after a successful presentation at ASCO, “ImClone presented an optimistic timeline of Erbitux approval based on Phase II data,“ as in the case of Gleevec developed by Novartis?!>>
Per protocol and trial execution, pts are stratified into two equally size group: A)PROGRESIVE after irinotecan and B) STABLE after minimum 12 weeks on irinotecan. This was done for a several reasons, and FDA agree with.
So, *refractory* is not valid for at least 1/2 of the enrolled pts, but not based on pts documentation. Based on enrolling criteria.
Article is correct, all MATERIAL info were available before BLA is filed, ONLY ONE HAVE TO SEARCH FOR IT.
Miljenko |
