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Biotech / Medical : Depotech(depo) -- Ignore unavailable to you. Want to Upgrade?

To: John McCarthy who wrote (611)	12/19/1997 3:20:00 PM
From: Czechsinthemail	Read Replies (4) \| Respond to of 887

John, At this point, NO ONE knows HOW WELL the product works versus a control group. From what I could gather from the conference call, I think there were pretty good indications of DepoCyt's benefits. The small numbers in the trial made the impact of a small swing on the difference between "evaluable" and "intend to treat" numbers into a big deal. I think that the disconnect between ODAC and the FDA people who negotiated with DEPO is the central problem. ODAC members apparently felt they had to uphold rigorous standards for statistical significance regardless of what the FDA had told DEPO. And lost in the side effects discussion was the fact that the two serious complications--one death and a CNS infection occurred in the control group. Again the problem is small numbers that make the results suggestive of benefit yet statistically insufficient. I think the results were encouraging enough to expect eventual approval. One other tidbit from the conference call. Apparently NM from solid tumors was chosen as the lead indication not because it was the strongest suit for approval but because it had the largest untreated patient population. The lymphoma/leukemia studies apparently have stronger results. I think DEPO management was confident enough in their product and their understandings with the FDA that they went into the ODAC meeting and got ambushed. Going forward from here, I'm pretty confident they will demonstrate the numbers to get an approval. Meanwhile, the stock is significantly oversold. It should have a healthy rebound once the smoke clears. Baird

To: John McCarthy who wrote (611)	12/21/1997 10:07:00 PM
From: John McCarthy	Read Replies (2) \| Respond to of 887

Thread - Below is one of the locations that is recruiting for the L&L&ST test. My purpose in posting this is, if you go their site and keep hitting the NEXT button, they seem to fine tune the criteria for an acceptable trial patient. I am wondering if the smaller test, the one reviewed by the ODAC panel, did in fact, alert DEPO to the requirement of a certain type of profile patient. Lastly, this site is VERY THROUGH in explaining to a potential trial member what they are up against. Against this backdrop, there is no, out of the ordinary mention of TOXICITY by the doctors that developed the site. act.musc.edu Lastly, if I have, in effect, wasted everyone's time I apologize in advance. I am still getting the hang of what's important and what's not. Regards, John