Seems like ths was the recommendation of a FDA working group. The group notifed VPHM of it's outcome. It would seem to me that the discussion has really just started. VPHM initiated a stay of decision, and working group or maybe GI division opens additiional discussion. Once this gets on the docket, it becomes public knowledge. I would think these discussions could go on for some time, with VPHM given chance to state case and mayb e bring in outside consultants, such as the Prof. from S. Carolina who discoverd the new NTX treatment. This was presented to us a 'done deal' but I don't believe that is the case at all. As level of ucertainty decreases, the pps will rise. it will be intersting to see how delays in final decsion would delay any potenial ANDA filings. Would a potential gneric proceed on risk, if this decision is prolonged for many months? I doubt it. Consequently, as the dicsusion is prolonged it is to Vphm's advantage, IMHO.
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