http://joinleenow.org/html/press/pdf/faq_a.pdf
If you look at page 4 on the above link, I think that this may answer
your question at least partially. I believe that the mouse studies that
they are currently conducting are part of the early Phase I Trials. The
human part of the studies won't begin until late in the Phase I Trial.
Also, here are some definitions that may be helpful:
PHASE I TRIALS: Initial studies to determine the metabolism and
pharmacologic actions of drugs in humans, the side effects associated
with increasing doses, and to gain early evidence of effectiveness; may
include healthy participants and/or patients.
PHASE II TRIALS: Controlled clinical studies conducted to evaluate the
effectiveness of the drug for a particular indication or indications in
patients with the disease or condition under study and to determine the
common short-term side effects and risks.
PHASE III TRIALS: Expanded controlled and uncontrolled trials after
preliminary evidence suggesting effectiveness of the drug has been
obtained, and are intended to gather additional information to evaluate
the overall benefit-risk relationship of the drug and provide and
adequate basis for physician labeling.
PHASE IV TRIALS: Post-marketing studies to delineate additional
information including the drug's risks, benefits, and optimal use.
Patsy
>--- In nathanfaustmantrials@yahoogroups.com, "imcimc1" <imcimc1@y...>
>wrote:
>
>
>>If they have technically begun clinical trials, what phase are they
>>in? Once the human trials start in 2007, what phase will that be
>>considered. Also, are they on this so-called "fast track" with the
>>FDA? That seems to be either a catch phrase for hope or a real push
>>with the FDA to expedite what seems to more than promising. I/m
>>
>>
>pretty
>
>
>>sure that Dr. Vinik's work at the Strelitz institute is on the "fast
>>track." Any feeback would be welcome, thanks!
>>
>>