Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Microcap & Penny Stocks : Tokyo Joe's Cafe / Anything goes -- Ignore unavailable to you. Want to Upgrade?

To: Eski who wrote (17017)	5/12/1998 10:24:00 PM
From: Henry Niman	Respond to of 34592

Here's the latest from Bloomberg: Cephalon, Chiron's Myotrophin 'Approvable' at FDA (Update1) Bloomberg News May 12, 1998, 5:50 p.m. PT Cephalon, Chiron's Myotrophin 'Approvable' at FDA (Update1) (Adds company comment, more details, history of approvable letters.) Washington, May 12 (Bloomberg) -- Cephalon Inc. and Chiron Corp.'s Myotrophin drug for Lou Gehrig's disease could be approved, pending the submission of further information, the U.S. Food and Drug Administration said. In a short public statement, the agency said it sent a so- called approvable letter to the companies. Generally, an approvable letter means the agency intends to approve the drug, provided the companies move to resolve outstanding issues, often involving labeling or manufacturing. In this case, however, the FDA asked the companies for more information from studies, and said the drug is ''potentially approvable,'' said Cephalon spokesman Jason Rubin. Such a request is unusual in an approvable letter and throws the future of the drug into question. ''We plan to meet with the FDA to clarify the conditions for approval and to determine whether these conditions can be satisfied,'' the two companies said in a prepared statement. The companies have already said they don't plan to conduct another full study of the drug. What happens from here could well depend on how much information the agency needs before issuing a final approval. ''The letter does not constitute approval, but does provide details on what additional steps the manufacturer needs to take in order to gain approval,'' the FDA said in a statement announcing the letter. An FDA spokesman declined to comment further. Unusual Twist Rubin said it's too early to characterize what exactly the letter means for the companies and for Myotrophin. ''We need time to digest the FDA's letter,'' he said. The letter is just the latest unusual twist in the Myotrophin story. It came late on a day that was a government deadline for a decision on the drug. The FDA has been under pressure from patient groups and many doctors to approve Myotrophin, which would be only the second drug available for patients with the debilitating disease, amid questions about its effectiveness. The news came after trading closed on U.S. markets. Shares of West Chester, Pennsylvania-based Cephalon rose 1 9/16 to 14 3/4 in trading today, while shares of Emeryville, California- based Chiron rose 7/32 to close at 20 11/16. The two biotechnology companies have seen their shares soar and plummet over the last two years on hopes and concerns about the drug. Approval of the drug is especially important for Cephalon, because the company has yet to win full FDA approval for one of its drugs. Its closest drug to market, a narcolepsy treatment known as Provigil, won preliminary FDA approval in December. If it wins final approval, Myotrophin would join Rhone- Poulenc Rorer Inc.'s Rilutek in the market to treat amyotrophic lateral sclerosis, or Lou Gehrig's disease. Rhone-Poulenc Rorer won approval to sell its Rilutek in 1995. Two Studies Lou Gehrig's disease, which causes muscle deterioration and eventually death, affects about 30,000 Americans. In weighing the companies' application for Myotrophin, the FDA has wrestled with concerns about a European study that failed to back up a strong U.S. study of the drug. It's been just over a year since members of an expert agency advisory panel rejected the drug, voting against recommending approval because they couldn't be sure the drug would work. While the U.S. study showed the drug could prolong and improve the lives of patients with the debilitating condition, the European study failed to confirm its effectiveness. Advisory panel members said they didn't know which study to believe. Cephalon, as yet unprofitable, saw its shares plummet 7 to close at 13 the day after the advisory panel hearing last year. --Kristin Reed and Kristin Jensen in the Washington newsroom