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

To: StockDoc who wrote (840)	10/16/1998 6:41:00 PM
From: John McCarthy	Respond to of 887

Doc - I'm really glad your here. I know you called it out last time - and expect you'll see it for what it is again - thats why - wait for me to catch up, ok? First things first - (1) Let's agree the FDA is NOT gonna change a thing with respect to its standards. <<I expect the FDA to keep its standards, however.>> (2) Why did the FDA invite them to enter another NDA? IOW,is this meaningless, civilized, politeness? (3) 11 out of 12 people are stone dead if they get H&N cancer. i.e. MTX and EVERYTHING ELSE sucks too. (4) and thats why ... I am still 'stuck on' the median survival times: <<and the median survival was 421 vs. 133 days (p = 0.19). >> and the fact that <<The committee was evenly split on the question of whether cytologic responses in patients with carcinomatous meningitis from solid tumors in the absence of clinical progression was a surrogate endpoint that predicted clinical benefit. >> So .... (5) In your opinion is this NDA real or are we just blowing smoke. To remind you, you said right up front last time that the thing would not fly ...for such and such reasons ... and it did not. Are the set of circumstances the same ...? Or is this different? In any event, it is good to hear from you! (I currently find myself the owner of ELN via NXCO. They seem to dabble in everything) Regards, John

To: StockDoc who wrote (840)	10/17/1998 1:01:00 AM
From: John McCarthy	Read Replies (1) \| Respond to of 887

Amazin' ... we are on with the ODAC for Nov 16th. Here is what is going to happen: (1) It will be approved. Then the FDA will approve it. Once out there .... (2) Doctors will use it for ALL Head and Neck cancers. The simple reason being ... it keeps people alive longer ... and peer pressure begets peer pressure .... (3) Once doctors get their feet wet, and gauge which of their patients can stand depocyt:they will start to use it for other difficult cancers .... where MTX or MTX and other combo's don't cut it. (4) This whole FDA thing ... is a farce. (5) Question:Is MTX a generic drug or is it made by one manufacturer? <g> (6) The original trial that Depo did with H&N WAS the largest H&N trial EVER DONE - ANYWHERE up until that point in time. And yes - that was only about 35 bodies. Regards, John