Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

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

To: axial who wrote (9872)	6/21/2002 12:08:20 AM
From: Joe Krupa	Read Replies (3) \| Respond to of 14101

Hi Jim et al. I meant to post on this a week ago but never got around to it. I watched a bit of the congressional hearings into the ImClone insider trading scandal, last week. In one day they had both the new CEO of ImClone, as well as an FDA procedural expert, testifying before the congressional committee. The committee was trying to determine at what point in the review process does the NDA sponsor become aware of the FDA's intent regarding either approval or rejection of the drug. This determination was essential to proving that the company's executives had foreknowledge when they sold their shares days before the FDA rejected their drug, Erbitux. Those witnesses testifying on behalf of the FDA said that due to the interactive dialogue throughout the whole review process, 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. The FDA expert witness then testified that there is no reason to ever not let the NDA sponsor know where they stand in the process. The FDA review process, he suggested, was to facilitate a drug through to approval and aid the sponsor if correctable deficiencies are found. Therefore the FDA is a friend to the sponsor rather than a belligerent adversary, who keeps the company in a guessing game regarding their odds. When pressed by the committee, the FDA person said that the main reason the details are not revealed to the public throughout the process is to protect trade secrets - other than this sensitivity, he said, the process is totally open. While this information was damning to the ImClone executives, it reveals a lot about where Rebecca Keeler's comments about the FDA arise. Rebecca first used the words, "it is with great comfort and confidence that we expect to receive FDA approval for Pennsaid" (paraphrase). She has since, on numerous other occasions, talked about "ramping up production for the US market" and "fully expect FDA approval." These words are completely consistent with knowledge Rebecca would have from the interaction with the FDA, as testified before congress by an FDA witness. At this late stage in the FDA process, the FDA would probably be the first to admit that Dimethaid would know if they are on the path to approval or otherwise. Therefore, unless Rebecca wants to spend many years behind bars, she is quite simply relaying to us, the shareholders, the fact that FDA has told her we are on the correct road to approval. If things were not on track, there is no way she could make the assertions she has. What she is saying are not guesses, but based on actual guidance as provided by the FDA. In conclusion, the ImClone hearings have helped me very much confirm my understanding of the FDA process. She has been told we are going to get approval and I believe she has been telling that to us for at least 6 months now. joe

To: axial who wrote (9872)	6/21/2002 12:13:07 AM
From: Montana Wildhack	Read Replies (1) \| Respond to of 14101

Hi Jim, Thank you. I certainly agree with you that it was Paul Martin. Jean was instrumental in helping keep the hogs from the trough even though as you say he was finance minister during some of our worst years for spending. Mediocrity. What can you say? Or as the seconds pass, what was I saying? Not great so far. Touching below the 2 year low in late June with no UK at all now and quite a while since we've seen Dioptic revenue. Getting some resolution earlier would have been nice; but, I guess we're not going to do anything easily. We'd better do something important soon though. Cash needed over the next 18 months to Dec 31/03 I would estimate at around 42 million without spending on new product development (fungal and WF10). I'm betting operational expenses average $5 million per quarter over the next 6 quarters plus the next two installments of OXO (Nov 02/Nov 03) in Cdn funds. It's obvious by the stock price running out of gas that we can't keep going like this much longer period, let alone trying to raise anything near what's needed just to keep the ship afloat. Like I keep saying, this is the summer. Therefore it MUST be exciting no matter what side of the street we're shoveling from. I continue to believe in success and never had much hope we would be early. We have now passed 125 days since the inspection announcement. Not early but not late given that we don't really know what that is. Good news somewhere soon would be a good thing. Wolf