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

To: Cal Gary who wrote (8380)	1/8/2002 11:27:48 AM
From: Montana Wildhack	Read Replies (1) \| Respond to of 14101

Hi CG, Lifting a short quote from a recently released private newsletter: Unlike Canada and the EU, plant inspections by the FDA are product specific. The inspection audited DMX' plant for its ability to manufacture PENNSAID™ in accordance with US Good Manufacturing Practices (GMP), exactly in accordance with documents DMX had filed with submission for approval. While passing the FDA inspection is not assured, the Varennes facility did pass an independent EU inspection by an inspector from the UK Medicines Control Agency before approval was received last year in the UK. Ms. Keeler hired independent consultants to audit the plant ahead of the formal inspection and McNeil did a prior inspection as well. An August 16 press release stated the Company was continuing "to recruit technical staff to meet its quality requirements in support of a pre-approval inspection by the U.S. Food and Drug Administration" which may indicate the company was receiving council directly from the FDA on how to ready the plant for inspection. If the auditor finds deficiencies, a Form 483 will be issued which provides for 3 classes of deficiencies: serious, rectifiable and minor. The auditor has six weeks to submit his report to superiors, who will formally submit the report to reviewers of the DMX submission at another division of the FDA. I agree that the probability is 80%, but, I would say 50% by Feb 11 and 50% by Feb 28. I also think a re-inspection would be difficult to assess from a timing perspective. This inspection was delayed once already back in September I believe. My own estimate is that it adds 4 months or so worst case plus the time to fix. I think this was fully in Rebecca's control and we pass first time. That 6.20 was fun for a while. The bollinger bands havent caught up with yesterday and staying more than 2 standard deviations out of the range for long means we're either going to blow or it pulls back to wait. Wolf

To: Cal Gary who wrote (8380)	1/8/2002 12:39:36 PM
From: Joe Krupa	Read Replies (2) \| Respond to of 14101

Hi Cal, No draw NR yet, and the Amigos are still united in their cause. I thought we'd see an NR yesterday based on an estimate that the current draw started December 5th (day last draw NR came). The delay could be easily explained by a couple possible factors. First, the draw may have started on the 6th, rather than 5th. Secondly, the half day on the 24th may not have counted as one of the 20 days. In any case, it is indeed starting to look more like $3.5 million rather than $3. Maybe tonight. joe