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Gold/Mining/Energy : Nuvo Research Inc
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To: Greg Spendjian who wrote (8588)1/30/2002 1:29:43 PM
From: Montana Wildhack  Read Replies (1) of 14101
 
Greg,

Like many here I have read a considerable amount of the
reams of information available about FDA processes. My
understanding and I consider it correct that the FDA
does not schedule a formal plant inspection until the
safety and efficacy steps have been completed and a report
has been given to the same committee that will receive
the inspection report.

Warren posted a graphical link from the FDA site which
illustrated this in a flow chart form which was the simplest
way to make that clear.

I hear that Rebecca is frustrated with Europe and was too;
but, I have written it off as an ongoing tortuous experience
which will be worthwhile in the long run.

The biggest threat I hear (aside from the temporary issue
raised yesterday concerning the TSE300) is the awareness
of the risks concerning the handling of the WF10 phase III.

I don't believe we have any information on which to base
a decent opinion - but am more aware. I call that TTIDNT.
(snort!!) - hi Jim.

The dual carbed power of Pennsaid/J&J and WF10 together
is (I'm agreeing with Jim and others here) important for
the realization of strength in the NASDAQ undertaking.

FDA/J&J is the single most important CURRENT play however
and I'm comfortable the inspection pass is the final test
of that aside from marketing/labelling decisions.

Looking up Warren Szyiko's posting through the search
feature is worthwhile to get a better understanding of
how the FDA processes relate to your point.

Wolf
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