My question is why is it estimated that it will take 5 years to get Remoxy through just on the basis of a label change, but NH was talking about a 30 day meeting right after July 14, w/3 possible solutions, and essentially 6 month time line after that if C1 meeting (or 10 if C2)? Now, as we begin October, nothing so far. Dianne made it sound like no new news on the SequestOx front (although she may not be in the loop). What's really the story? Are we looking at a C1 or C2, 6 months, 10 months, 5 years? We have not bothered to submit to Health Canada or EU where much faster and easier--why???
IMO, the company has the income to stay afloat for whatever time it takes for the current ANDA's submitted to go through, and ultimately, a SequestOx resolution; but limited in it's funding to aggressively pursue more R&D endeavors based on the two bead technology. Clearly if the CRL was purely "fatty food" based and no labeling option given, then someone at the FDA intentionally put the brakes on us. Corruption of a Washington-run entity? Califf in the pockets of BP? Impossible to imagine? We got screwed, and very possibly the screw job continues--nobody had more to gain from approval than NH.
IMO--we have a multi-billion dollar technology and significant generic pipeline, but were all getting older. Time for NH to get a good price and sell the farm, IMO.
Maz
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