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Gold/Mining/Energy : Nuvo Research Inc -- Ignore unavailable to you. Want to Upgrade?

To: Joe Krupa who wrote (9873)	6/21/2002 12:27:26 AM
From: Montana Wildhack	Respond to of 14101

Joe, the NDA sponsor is kept well aware of which direction the review is proceeding towards. It was further said that the NDA sponsor has a very good idea, well in advance of a decision, if the drug will be approved or rejected and that it was virtually impossible for a company to think they are about to get approved when in fact rejection is on the way. I can see how this is useful. It would prevent companies from going to major expenditures like hiring and training (not to mention employing) a sales force in the dark. (ahem) To be fair, HC put in these rules to prevent undue influence from the powerful drug companies. This is an accusation that has recently been speculated about the FDA. I'm in agreement on FDA though. Despite my insistence on keeping the do or die summer up in the crosshairs, I'm quite certain we're in labelling discussions and I am certain that J&J is serious. Just as I see no possibility that WF10 could not be siginificant (based on statistical probability). We do absolutely need to close the Pennsaid side of things out successfully somewhere in the next 3 months or so though. Thanks for the FDA information. Everything confirms REK knows where she stands. Wolf

To: Joe Krupa who wrote (9873)	6/21/2002 1:06:40 AM
From: axial	Read Replies (1) \| Respond to of 14101

Joe, well said - Your logic is impeccable: the transfer of FDA applicability from the ImClone hearings to DMX is entirely correct. I'd like to add support for your thesis from a slightly different direction. In her public statements, RK was at pains to emphasize FDA-like behaviour. She was careful not to juxtapose it with HC-like behaviour - but her repeated emphasis on the benefits of dealing with the FDA were a clear reflection on the problems of dealing with HC. I'm working from memory here, but I remeber clearly her emphasis on the favorable aspects of FDA: collaborative; consultative; cooperative. Yes, without stating it explicitly, she made it clear that she was working with the FDA on approval. That was the shared goal. It was also very clear by her emphasis, that these were not characteristics she encountered with HC. Again, without an explicit statement, I got the clear impression that she had been led to believe, by HC, in approval. She apparently felt, initially, that HC was as trustworthy as FDA in its dealings with DMX. It must have been a bitter disappointment to have HC turn the tables: especially after HC's holding applicants up for more money, especially after investing the resources in a sales staff, especially when looking ahead to a year with no revenues. Especially when the required data, apparently, was already before HC's eyes. But back to your point: everything RK has said is consistent with your comments. There is absolutely no reason to believe that FDA has any aim, at present, other than approval. There is absolutely nothing in the data (that we know of) that mitigates against approval. The present share price seems to speak to a woeful future. The facts, and their sensible interpretation, say otherwise. Thanks for taking the time to get all that down on "paper". You're right on, IMO. Good stuff. Jim