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Gold/Mining/Energy : Nuvo Research Inc
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To: Cal Gary who wrote (8380)1/8/2002 11:27:48 AM
From: Montana Wildhack  Read Replies (1) 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
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