Hello Folks,
I'm just working my way through the NeuroInvest website (http://www.neuroinv.com/). What a great read! It's wonderfully entertaining, with tons of information. btw, I'm not a subscriber, and don't know enough to evaluate Dr. Harry Taylor and his analysis ... just wanted to pass this on.
for example:
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from Dr. Taylor's Interim Comment on the CEPH / FDA Myotrophin circus, sent to subscribers 3/21/98:
"We have not been able to derive any sense of certainty how this will go:
an AP ruled by dominant personalities has had three wild cards added.
New members tend to initially adhere to the expectations of the extant
culture, and thus their votes cannot be assumed. It is, to speak
colloquially, a 'crap shoot.' Because of this, we are amending our
recommendation. Anyone following NeuroInvestment for any period of time
knows that we do not shy away from controversy and risk: however we have
seen the light at the end of the tunnel, and it is increasingly looking
like an oncoming train, with Drs. Leber and Gilman at the controls."
.
it's a little dense, but hard to beat for in depth coverage of a company and an event ... : )
.
/* full text of the 3/21/98 comments
INTERIM COMMENT: (sent to subscribers 3/21/98)
The March issue of NeuroInvestment, which went to press on 2/20/98,
included a positive review and recommendation of Cephalon. At the time
that issue was published, there had been no announcement of a third
Advisory Panel for Myotrophin.Upon our return in early March, we began
to look at the implications of the AP meeting scheduled for 4/9/98, one
that no one, including NeuroInvestment, had anticipated. There will be
three new voting members participating, one of whom has experience with
clinical trials of CNTF in ALS (thus satisfying the requirement that
someone on an AP have experience pertinent to the disorder being
addressed.) With two members of the previous panel having departed,
those remaining had voted 5-2 against Myotrophin (in terms of the
European trial providing adequate support for the US trial). If those
individuals were to vote the same way on the 'should Myotrophin be given
approval' question, the best that could be hoped for is a 5-5 draw.
Of greater concern is the increased ambiguity about what is going to
actually be presented to the AP. We had been assured by various sources
that T-IND data had been given to the FDA, and our hypothesis has been
that this was enough to shift the tides in favor of approval. To this
point however, the Company has not commented on whether that data will
even be presented to the AP; since it is uncontrolled data of limited
statistical value, it is not clear how this statistically-oriented AP
would even respond to T-IND information. In talking with our sources, it
is not clear that Cephalon will be going into that AP meeting armed with
much more than they had last year. There has been conjecture about a
request for 'fast track' consideration: never would that term be more
inappropriately utilized. A Phase IV trial has always been our
assumption, the question is whether this AP can shift position and go
along with that, and if not, will the FDA respond to enormous pressure
(e.g. 11 Senators have signed a petition calling for immediate approval)
and overrule their AP.
We have not been able to derive any sense of certainty how this will go:
an AP ruled by dominant personalities has had three wild cards added.
New members tend to initially adhere to the expectations of the extant
culture, and thus their votes cannot be assumed. It is, to speak
colloquially, a 'crap shoot.' Because of this, we are amending our
recommendation. Anyone following NeuroInvestment for any period of time
knows that we do not shy away from controversy and risk: however we have
seen the light at the end of the tunnel, and it is increasingly looking
like an oncoming train, with Drs. Leber and Gilman at the controls. The lack of leadership at the FDA, perpetuated by the absence of a
Commissioner, means that we cannot assume that patient needs will
prevail over bureaucratic ego. We do not suggest standing in the path of
this train. If Myotrophin is rejected, the stock will go down to 8-9,
and would be a buy because of Provigil's prospects, though its recovery
would take many months. If it is approved by the AP, it will go up to
18-20, and then would be a buy during subsequent profit-taking, because
of the prospects for both Myotrophin and Provigil. With just as much
downside risk as upside potential, conservative investors will want to
sit this one out, waiting to see what will occur on 4/9. Our longterm
view that Cephalon has value continues, but the AP meeting now looms as
a potential major obstacle to the seemingly straightforward progress
that we had forecast in mid-February. Our buy recommendation is retrac
ted until the AP meeting has taken place, and those not willing to ride
out a potentially very tumultuous period should carefully assess their
exposure at this time. If at some point before the AP meeting there is
some substantive disclosure regarding new information that will be
presented on 4/9, that could warrant reconsideration. |
