Just the choice of words reported to have come from Fisher...
"We are pleased with how the meeting went with the FDA," said Dr. Charles Fisher, Executive Vice President and Chief Medical Officer of Cardiome. "Astellas and Cardiome will reflect on the discussion and, following consultation with their partner, expect to be in a position to provide further guidance to investors in the near term regarding the timely and accurate re-submission of the N.D.A for RSD1235.
Too many wishy washy, abstract, non specific verbs and phrases designed to leave a positive impression but which give no definitive deadline for anything and no definitive statement of the process that will lead to an NDA. I get the impression that if he could have said, "We're going to submit the NDA by next Tuesday", he would have. period. Instead he has to REFLECT for an indeterminate period of time, then CONSULT for an indeterminate period of time, and, only after all that, will Fisher PROVIDE FURTHER GUIDANCE to investors. The nature of that guidance is nonspecific and, based on the statement alone, could be for a very time consuming process eventually leading to a resubmission.
I have no position, have never had a position, and based upon the snippet from Fisher, have no interest in establishing one.
Ian |
