This negative information was published by CEPH upon their latest stock offering of 1.5 million shares to the SEC at sec.gov
Please review official SEC document or attached and give me your opinion. I have shorted this stock at 26 and wanted to know if I should wait until it hits 18, 20 or really wait for it to tank! Please advise.
In 1995, the Company submitted to the United States Food and Drug
Administration (the "FDA") a treatment investigational new drug application("T-IND") to permit expanded access to MYOTROPHIN (rhIGF-I) by patients in theUnited States suffering from ALS. The FDA referred the application to thePeripheral and Central Nervous System Drugs Advisory Committee (the "AdvisoryCommittee"), which held a public hearing in June 1996 to review data from twoPhase III studies, one conducted in North America and one in Europe, forpurposes of recommending to the FDA whether there was sufficient evidence to
support use of MYOTROPHIN (rhIGF-I) under a T-IND. At the hearing,
representatives of the FDA indicated their disagreement with the Company'svarious analyses of the European study and their opinion that the study failedto support the results of the North American study. At the conclusion of theAdvisory Committee hearing, the panel members unanimously recommended approvalof the T-IND.
The FDA approved the T-IND application on June 19, 1996. The FDA's approvalletter noted the views of several Advisory Committee members at the hearing,including the chairman, concerning the need for an additional study to support aNew Drug Application ("NDA"), and invited Cephalon and Chiron Corporation("Chiron") to work with the FDA to develop plans for future studies. The Companycontinues to believe that the two completed studies show the beneficialtreatment effect of MYOTROPHIN (rhIGF-I) in ALS patients, particularly thosewith more rapidly progressing disease and, in collaboration with Chiron,recently
filed a NDA with the FDA requesting that MYOTROPHIN (rhIGF-I) be approved forthe treatment of ALS in the United States.
There can be no assurance that the FDA will ultimately grant authorizationto commercialize MYOTROPHIN (rhIGF-I) in the United States on the basis of theresults of the two completed studies. In connection with its review of the NDA,the FDA may seek the Advisory Committee's recommendation as to the safety andefficacy of MYOTROPHIN (rhIGF-I) in the treatment of ALS, some of whose membershave expressed the view that an additional study is desirable. The Company has
indicated its willingness to conduct additional studies of MYOTROPHIN (rhIGF-I)as a post-approval activity. If the FDA were to require additional data prior toapproval of MYOTROPHIN (rhIGF-I) for commercialization, there can be noassurance that Cephalon and Chiron would be willing or able to conduct eitherthe planned study described above or any other study as a Phase III activity orthat the results of such study, if conducted, would be positive. Any new studywould be expensive and would take several years to complete.
Because ALS is a fatal disease, it is expected that some mortalities willoccur while conducting clinical trials in ALS patients. During the double-blindportion of the European study, an imbalance in death rates was observed in thedrug-treated group compared to the placebo-treated group. The Company believes
that mortalities observed in the North American and European clinical studiesare due to the normal progression of the disease or other circumstances notattributable to MYOTROPHIN (rhIGF-I). FDA regulations require the reporting ofall patient adverse events experienced in ongoing trials. The Company iscontinuing to furnish MYOTROPHIN (rhIGF-I) to patients who participated in theALS studies, to patients in its Phase II program in peripheral neuropathies, andto patients under the recently initiated T-IND program. There can be noassurance that adverse events will not occur and that the reporting of any suchevents will not result in any subsequent FDA action adverse to the Company.
The efficacy and safety data from the North American and European studiesof MYOTROPHIN (rhIGF-I) have not yet been formally reviewed by any regulatoryauthority outside the United States. If foreign regulatory authorities do notagree with the Company's interpretation of the results from the two studies, oneor more additional positive studies might be required to be completed andsubmitted before MYOTROPHIN (rhIGF-I) could be marketed in such territories.
There can be no assurance that any regulatory authority will accept the
North American and European studies as evidence of sufficient safety and
efficacy to support marketing approval or that MYOTROPHIN (rhIGF-I) will receive
marketing approval in any jurisdiction for any indication. A delay in obtaining
approval or a failure to obtain any approval for MYOTROPHIN (rhIGF-I) would
seriously adversely affect the Company's business and the price of the Common
Stock. See "Volatility of Stock Price; No Dividends".
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