Wednesday, November 14, 2007 12:18:52 PM
>> Tell the FDA to treat it as an active application, which digs the FDA into an immovable position in rejecting it (see Dew Diligence's reference to "cement"; 2) Withdraw the application, which would mean starting all over again if they achieved anything with behind the scenes negotiation; 3) Inactivate it, which leaves it in limbo, which may the best option they had at the time--IMHO was the best option.<<
I appreciate your response. I am far from convinced, being that occurances of flat out rejection are rare, that putting the application in limbo was the best solution to an unknown problem. How can you be sure that the FDA would have drawn the line in the sand with regards to CX717 if rejections are indeed that rare? Why not let the process play out its course and receive findings from the FDA and proceed from there? What would that hurt at this point? The damage, as a shareholder, had been done.
I do not, nor will I ever, claim to understand the full and detailed process of which drugs are advanced to market, I am, as a shareholder, trying to understand the actions and reasons of our chiefs decisions. Thanks in advance, I have to get to get back to work.
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