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Biotech / Medical : Paracelsian Inc (PRLN)
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To: Richard Mazzarella who wrote (1051)12/12/1996 1:35:00 PM
From: Rick Costantino   of 4342
 
I see your point, but remember that Phase I is only intended to test
for safety, not efficacy. I am surprised they demonstrated any
efficacy at all, and I don't blame them for highlighting it in their
release. In the pharmaceutical industry, researchers are ecstatic
when they are able to see efficacy in Phase I.

What I'm saying is that the release is positive in that it shows
that the drug can be tolerated at therapeutic doses (however, they
didn't elaborate on the hypersensitivity case, as Robin asked about).
There is no surprise here. Again, I was pleasantly surprised to see
the efficacy.

The real important result is the Phase II. Phase II is the make-it-or-
break-it stage, where you rigorously examine efficacy in a relatively
small population. I was dissapointed not to see any mention of AndroVir
starting Phase II. (Did I miss it?) Perhaps they plan to get a larger
company to collaborate to share costs with and are not ready to
announce it yet?

Another point of dissapoinment for me was that they did not mention the
molecular mechanism of action. They made a big deal of this during
their conference call way back when. When will they publish these
observations?

I am not worried about the "rush to product" at all. I am investing in
PRLN based on the value of their drugs in the pipeline and their
ratio of value-to-risk with regards to FDA approval. The fact that
they plan to in parallel also sell product without an indication is
fine with me since it will generate some income. As long as it doesn't
disrupt their develoment timeline.

Maybe I missed it, but where/when will the cocktail tested? Cocktail
with what? Is this in a Phase I study also?

Rick
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