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To: Greg Spendjian who wrote (8664)	2/7/2002 8:11:29 PM
From: Michel Thibodeau	Read Replies (1) \| Respond to of 14101

From stockhouse ??? What specifically is a "notice of noncompliance"? Does that mean it is simply not approved period and the reply from Dimethaid is some sort of appeal? Or does it mean they have yet more questions about the approval submission? Any idea??? Michel

To: Greg Spendjian who wrote (8664)	2/7/2002 9:04:30 PM
From: axial	Read Replies (3) \| Respond to of 14101

Hi, Greg - With the successful completion of the U.S. Food and Drug Administration's preapproval inspection of its Varennes, Que., plant last December, Dimethaid fully expects the review of its U.S. New Drug Application for Pennsaid to be completed in a professional and timely manner. You are absolutely right to say the statement can be read two ways. The meaning is ambiguous. From my research, it is entirely possible that REK has been privately notified by the FDA, at this point, but has not yet received the report. However, the words do not say the inspection was successful, they say that the inspection's completion was successful: that is, the inspection was not cut short, or terminated. Rather, it ran its whole length. The other aspect of this question is the fact that REK is extremely careful in her comments. My interpretation of the FDA matter is that the FDA report will not be released, but she will be free to announce the results of the report. That being the case, I would expect a much less ambiguous statement if she had, in fact, received the report. But who knows? Certainly, REK knows how to make herself clear, if need be. It certainly was nice to see her throw some clear shots at HC. Good on ya, Becky. Maybe you are right to attribute success to her intentional ambiguity. "Mind you, at this stage until we see things unambiguously stated there will be some doubts." Yeah, there's a whole truckload of professional doubters over on SH, bought and paid for. As others have said, pharma is a dirty biz. There'll be a dumpster full of harebrained theories, designed to baffle newbies, and a big recital of every error, real or imagined, ever committed (or not committed) by DMX, culminating in a grand aria by the lead bashers, who will sing, to the tune of Handel's 'Hallelujah Chorus'... "Aaaaaskin' questions! Questions, askin' questions!" ...and then will turn, with an expression of wounded innocence, and say, "Who, me? What'd I do? I'm just trying to protect you!" Who ARE these guys? Do they really think they're fooling anybody? Regards, Jim