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Steve, these are good questions. I'll give my opinions. << 1. Is drug in a better or worse standing than before panel?>> Myo has always had strong endorsement by the ALS community. Its standing within the FDA
likely hasn't changed since CEPH did not present any new, relevent data. The standing of CEPH management is another story. << 2. What is the next drug and when will it even get approval?>> CEPH's next drug
is Provigil, a treatment for narcolepsy. An FDA panel meeting is anticipated later this year. Actual approval, of course, is TBD.
<< 3. Did CEPH invest in there own approval and get burned, as of now?>> I don't understand the question. CEPH, of course, has a vested (financial) interest in seeing Myo approved. Ditto Chiron. If you're referring to the option play, that was an extraordinarily arrogant decision by CEPH management.
<< 4. Is drugs CEPH working have great market?>> If Myo is approved in the U.S., its penetration of the market likely will be close to 100%. CEPH would have little competition here; the next potential new drugs for treating ALS are at least 2 years away from FDA review.
<< 5. How is the near term cash picture now that Myo now is look on
infavorably by panel?>> According to CEPH's recent 10-k, they have $146.8 million in cash and equivalents and are burning at a rate of
$53 million per year. At the current burn rate, they have cash for another 3 years of operation.
That is a very very healthy amount of cash for a development stage biotech. << Did Myo committee vote against help it?>>
Well, all I can say is that U.S. approval of Myo is very much in the hands of CEPH management, and they have a substantial financial interest to see this through.
Also, CEPH will in the near term submit an application for Myo approval in Europe. The story's not over. Rudy |
