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Biotech / Medical : Imclone systems (IMCL)
IMCL 0.1590.0%Oct 5 5:00 PM EST
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To: Fred Levine who wrote (2010)2/13/2002 3:27:08 PM
From: Cacaito  Read Replies (1) of 2515
 
MerckAg is delayed in Europe cause of Imcl, just go and check today press release from MerckAg, they were planning to apply with Imcl pII colorectal trial data in Europe. MerckAg own trials are ongoing pIII studies expected for end of the year.

Telephonics is right no phase III were presented to the FDA, phase II (without placebo control and not blinded) were used for the BLA application.

The EGFR is present in many type of tumors and pancreatic tumors is one of those. The woman that got better also has standard treatment including surgical extirpation of most of the pancreas, if not part of a good trial design it is just a good anecdote (I said good because the oncologist from MD Anderson Center are experts that can provide a report with good chances they are right and Erbitux contributed to her well being), still is nothing more than "potential".

MerckAg paid $60M for most wordlwide rights and half the Japan revenues, they were early investors with more risks than BMY (turns out that BMY risks were as high!).

European trials are as good as the USA and many times done in regulatory synchrony with the FDA, the source and planning is the key, not that Europe has lower standards all the time. Actually, American products trials have as much hard time in Europe as the European ones in America, and when a firm like MerckAg is taking most of the revenues they are easier for an American product. Imcl is relatively in very good shape cause of their MerckAg agreements and chances. European stringency have been increasing for the last two decades even for European pharma. It has been more so with increase EU integration.
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