An SPA offers a binding agreement that the scholarly research design, including trial size, scientific endpoints and/or data analyses is acceptable to support regulatory approval. Resource Chelsea Therapeutics International, Ltd.. Chelsea completes successful NORTHERA pre-NDA assessment with FDA Chelsea to File for US Marketing Authorization of Northera in Symptomatic Neurogenic Orthostatic Hypotension in Q2 2011 Predicated on Efficacy Data from Stage III Research 301 and 302 FDA WON’T Require Study 306 seeing that Second Pivotal Study for NDA Management to Host Conference Contact in 9:00 AM ET Chelsea Therapeutics International, Ltd. announced it has completed a pre-NDA evaluation with the U.S.S.‘People now with that disease receive a tablet, and a tablet is taken by them, and many of these social people look like cured, not helped just, but cured.’ One major plus for leaving chemo is that individuals will not have to deal with the severe unwanted effects of the drug. Kris said that while these targeted treatments have side effects, they will vary than those that are associated with traditional cancer treatments. ‘There is very little lack of hair, very little harm to your nerves, very little harm to your blood which could lead to attacks and bleeding and all the things that people associate with chemotherapy,’ he said. For Dr. Mark Kris’ full interview, watch the video in the player above..