Kees33 schreef:
Trendbreuk na maanden en maanden slechts aankopen te hebben gekend.
tinyurl.com/oejspOverigens had memy slechte berichten.
Memory Delays Study Over FDA Concerns
Thursday June 1, 4:52 pm ET
Memory Pharmaceuticals Delays Clinical Trial Over FDA Concerns About Purity of Materials
MONTVALE, N.J. (AP) -- Memory Pharmaceuticals Corp. said Thursday it is delaying the start of a mid-stage clinical trial for its Alzheimer's treatment candidate over concerns by the U.S. Food and Drug Administration.
ADVERTISEMENT
click here
The concerns are over the potential for impurities in the clinical material the company proposed using in the Phase 2a clinical trial of MEM 3454. The trial's goal is to determine the drug candidate's effectiveness in treating Alzheimer's disease as well as determining side effects. The company released the news shortly after the market closed. Shares of its stock rose 14 cents, or 8.1 percent, to close at $1.87 during regular trading on the Nasdaq.
"We are committed to resolving this issue as rapidly as possible," said President and Chief Executive Jim Sulat in a statement.
The company is considering using another batch of MEM 3454 made using a different manufacturing process in place of the suspected impure batch in order to address the FDA's concerns.
The trial, originally scheduled to start this month, is now expected to begin later this year.
Memory is focused on developing drugs to treat central nervous system disorders and neurological diseases. Approximately 4.5 million Americans have Alzheimer's disease and that number could continue to grow to 16 million people by 2050, according to advocacy group Alzheimer's Association.