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Biotech / Medical : Neurex Corporation -- Ignore unavailable to you. Want to Upgrade?


To: NeuroInvestment who wrote (395)1/15/1998 7:45:00 PM
From: John McCarthy  Respond to of 449
 
NeuroInvestment:

Sorry you had to wait for me, and perhaps others, to catch up.

In order,

(1) Can't apply numbers to my matrix (prior post) because NXCO
is blind to the specific numbers of this interim report. i.e.
no detail available

(2) Nothwithstanding the numbers, it would be logical to think
that if there were a problem with "intent to treat" population
vs "evaluable" population, NXCO, to stay in sync with current FDA relationship , would maintain a patient accrual so that evaluable population count was satisfactory.

(3) Neuropsychiatric side effects do not seem to be apparent
with #Z# as opposed to competitive NMDA antagonists.

(4) Blood pressure issues have more to do with the use of #Z#
with respect to head trauma. With respect to this indication
the doses of #z# are much higher i.e. 70 mg per day.

(5) Competitors :

NTIIC (Neurobiological Tech) has a Phase 2 coming out,
if OK they'll seek partner and run to Phase 3.

Sept . Cash 2.3
Qtr Cash out 1.3

I hope I got your points and will be able to contribute
constructively to this puppy.

Regards,

John



To: NeuroInvestment who wrote (395)1/15/1998 7:55:00 PM
From: Dr. John M. de Castro  Read Replies (1) | Respond to of 449
 
I think you're being overly optimistic here. This is the same tune that I sang with DEPO.

> If there was such a high dropout rate that one might run into treatable vs evaluable sample power issues,

The issue is to some extent power. However, if you treat dropouts as non-responders, then you greatly dillute you 40% improvement in your evaluable group. This effects both power and effect size. DEPO ran into trouble because of the impact of including drop-outs on the effect size.

> Neurex and the FDA have been on the same page throughout this process

This was also true with DEPO. The problem was the ODAC was on a different page. There is no assurance here that FDA agreements with NXCO will mean anything to ODAC. They sure didn't with DEPO.

> 2) If you want something genuine to worry about, look for the release of the neuropathic pain Phase II data from the Neurobiological Technologies memantine trial, due out late Jan/early Feb. While I expect memantine to have less magnitude of effect, it is given orally and thus is a lot cheaper and easier to utilize. If successful, NTI would push a Phase III partnership ASAP, since they are near bankrupt.It could be a competitor for the mild-moderate range of neuropathic pain patients.

Now here I agree with you. NTII is in a great position because they are addressing the really huge neuropathic pain market. NXCO is only addressing a relatively small niche market. The reason to suspect that memantine will be less potent is because it is a noncompetitive NMDA antagonist. This is actually good. It maybe slightly less potent. But, it has a proven record of safety with humans for over 15 years.

I own NTIIC stock and do not own NXCO. So take my self serving comments for what they are worth.

John de C