"gabapentin" with the SAME safety concern is ALREADY approved for epilepsy. So, FDA will hear the appeal and will approve, with appropriate warning label because
Today's shakeout is the best buying opportunity, IMHO.
I agree with you that the posibility of approval still exists for another reason.
I read through all the press releases and comments and NEVER found the FDA language of NOT APPROVALABLE!
Of course I never found NON-APPROVABLE either but I believe the window is still open.
So there is a possibility that based on the safety of approved API gabapentin and possibly with warnings, they may be able to get approval.
Listen to the conference call, watch to see if GSK severs the deal....if not, then this could pull a DNDN move.
At these prices which are only a $1 above cash levels, there's a BIG upside with lower than average risk ....in biotech.
Hi Cardio and Titan,
you gusy a ppear to right and CARDIO appears to have called it with the answer being whether the GSK deal is extended
see news just out!:
Feb 18, 2010 (Datamonitor Financial Deals Tracker via COMTEX) --
XenoPort, Inc., a US-based biopharmaceutical company, has signed a co-promotion agreement with GlaxoSmithKline plc ( GSK | Quote | Chart | News | PowerRating), a UK-based pharmaceutical and healthcare company, for Solzira (Gabapentin enacarbil) extended release tablets in the US.
Under the terms of the agreement, XenoPort will share profits and losses from the potential future sales of Solzira in the US. XenoPort has exercised the option contained in its development and commercialization agreement with GSK to co-promote Solzira.
Solzira is the subject of a new drug application (NDA) that is under review by the US Food and Drug Administration (FDA) as a potential treatment for moderate-to-severe primary Restless Legs Syndrome (RLS).
You guys have no clue in FDA approval.
FDA can approve one drug with bad side effects, eg vomiting and falling hairs to cure colon cancer. But it will never approve this same drug for common cold. Got it?
your statement as lame as it gets. Obviously, your are not in health profession and thats not your area of experties!!!! Gabapentin already is being widely used by neurologists and pain clinics for chronic fibromyalgia ( leg pain due to nerve misfiring).!!!!!
They found a spot of cancer on one single female rat who had a suspect night life that included drugs and unprotected sex while laying in asbestos bedding while in a stupor of hard liqour. She was a tramp and a vamp and a bit of a scamp besides being of the weaker sex (the one less likely to need rapid leg treatment. Lies, Damned lies and statistics remain the three kinds of lie