May 26, 2010
– Comments (5) |
RELATED TICKERS: XNPT.DL
that says to me that its giving us the green light to go short at will. No chance of going up after today's news could not do it.
your "pitch" on this.
I like XNPT.
oh, sorry, that pitch was by ibdvalueinvestin.
In February 2010, XenoPort, Inc. (“XenoPort”) and GlaxoSmithKline (“GSK”) announced that GSK received a Complete Response letter from the U.S. Food and Drug Administration (the “FDA”) regarding the new drug application filed in January 2009 (the “NDA”) for Horizant™ (gabapentin enacarbil) Extended-Release Tablets for the treatment of moderate-to-severe primary restless legs syndrome (“RLS”). The Horizant Complete Response letter states that the FDA concluded that the NDA provides substantial evidence of effectiveness for Horizant as a treatment for patients with RLS and that the FDA had not identified a clinical safety concern that would prevent approval of the 600 mg dose of Horizant . However, a preclinical signal of pancreatic acinar cell tumors in rats was determined to be of sufficient concern to preclude approval of the Horizant NDA for RLS in its current form.
On May 18, 2010, XenoPort and GSK conducted an end-of-review meeting with the FDA in which the content of the companies’ planned Complete Response letter resubmission regarding the Horizant NDA for RLS was discussed. During the meeting, the FDA suggested additional preclinical data and data analyses that may be useful in the evaluation of the resubmission, and the companies are evaluating this additional work. No new clinical trials are expected at this time. XenoPort expects the Complete Response letter resubmission will be filed with the FDA in the second half of 2010.
your earlier post on XNPT (this time really yours, hehe).
also see this pitch by zzlangerhans.