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Biotech / Medical : Depotech(depo)
DEPO 7.300+1.7%Aug 14 5:00 PM EST

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