This raises questions, particularly in light of the wording of the document (disparaging remarks!) and the advice for her to "review it with her attorney." It could be that there is some aspect of the Transave lawsuit or the MMD lawsuit that popped up and was magnified out of proportion. If she was doing her job and this was a forced-out situation, that could be the reason for the wording. Remember also that she was the Secretary to the BOD, so she knows what is going on at that level. It also makes me think that they may have wanted to use her position as a VP to hire a more accomplished regulatory person. That VP of regulatory has appeared and disappeared several times during the last two years. The are going to need an international expert on FDA, EMEA and other marketing countries to get world wide rights. And it would be better to do this sooner rather than later. This may have been brought to a head by a whopping invoice from Chiltren that handled the EMEA regulatory for CF/Pa in Europe and Canada. If you review that contract, it was pretty extensive and the final invoice would probably have been $millions. They oversaw all the clinical data accrual, collated and analyzed the data and produced the final reports that are going to be the lead in for regulatory approval. The use of that data to get FDA approval is certainly a demanding regulatory issue besides. I guess we are going to have to wait for the information here the same way we had to wait for the rat carcinogenicity info. I am a bit surprised by this, but not really in view of various corporate needs to diversify and strengthen.
So, Whitten's knee-jerk hire when the Clinical Hold #$%$ hit the fan, I suppose. ? Astonishing the amount of money and options spent in the last couple of years. Can only imagine what the *new* guy will receive. If the data is great and this indeed is Mr. Lewis getting his/the *ducks in a row*, then it will all make sense.