Peace ?
Ask those perpetrators,, the pissers,, jealous dogs ,, with penny scams,, front running dogs..
Who needs them ,, more MDIX ? TNRG ? FAMH ?
309 now and growing .. we discuss stocks ,, not one liner garbage..
CEPH ....MONDAY IS DAY FOR FINAL DECISION....
FDA Advisory Committee to Meet on Myotrophin April 9
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The new drug application for myotrophin will be considered once again by the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA).
A public meeting is scheduled for Thursday, April 9, 1998 at the Holiday Inn in Bethesda, Maryland from 8:30 a.m. to 5:00 p.m. with an open public hearing from 8:30 a.m. to 9:30 a.m. The committee will provide the FDA with a recommendation by end of the meeting.
As in the past, the Committee can vote to recommend approval to the FDA of myotrophin, or it can vote not to recommend FDA approval. The FDA is not bound by either recommendation in reaching its decision on myotrophin by the target goal of ********May 11, 1998.
The ALS association has asked patients and family members who can be effective spokespersons to testify at the open public hearing. Requests to speak during the open hearing should be directed to Ermona McGoodwin at the FDA (301) 443-4695 phone, (301) 443-0699 fax.
This is a second chance for the drug and its manufacturers, Cephalon and Chiron. The advisory committee voted 6 to 3 May 8, 1997 to not recommend approval of myotrophin, saying there was not substantial evidence that myotrophin, also known as IGF1 (rhIGF-1 or mecasermin) is effective in the treatment of ALS. In November, Cephalon and Chiron announced that they were withdrawing and resubmitting the companies' new drug application (NDA). By withdrawing and resubmitting the NDA, the companies enabled the FDA to continue its review.
Many ALS clinicians, researchers and patients have urged approval of the drug. It had shown positive results in several tests without harmful side effects, and has been designated an orphan drug for ALS treatment since 1991. Drug treatments for ALS are limited, with only one drug - Rilutek - approved by the FDA so far.
---Information from the FDA, the ALS Association, and previous reports. |
