just what are the labeling issues at hand with the FDA?...does anyone know?...all I've read does not go into detail...this stock is tanking because an "approvable" drug is FAR from an approved drug...while optimism reigns, whatever the labeling issues are could adversely affect the uses of this drug and therefore the potential revenue it may generate...Brewer has stated that Scios still plans to market this drug in the 3rd quarter...is the FDA on board with this too?...remember, the Feds are driving this bus still, and if they don't like the labeling come the Q3....yer lookin' at next year if your lucky....Good Luck kids....
From what I read in the Advisory Panel minutes that bruno sent out, there were concerns about giving nestiritide patients having low wedge pressure and high ejection fractions. Also they want the dosage to be limited to the dosing regimen used in the VMAC study because of the pharmacokinetic and pharmacodynamic effects on patients. Also, patients taking the drug should have dypsnea at rest.
Start with page 300 of that document. Since I am only an electrical engineer with no knowledge of ischemia or for that matter heart failure in general, you should read it. I left out some other key elements that I hope people on this board openly discuss.
Will the knowledgeable board members start a dialogue on the issues please?
PS -- If you don't have the document just go to msg# 20921 and download it.
The FDA has stated that they are very happy with the wording of the label (in fact called it excellent) and all they want now is for SCIO to have it officially printed up in the format it will be in the package and let them review it once more. NO BIG DEAL and should be done in a couple of weeks. The FDA's vacation schedule is a bigger concern than this. As far as I'm concerned, we are APPROVED.
Think you're overly pessimistic. According to the call last night, the FDA has already approved the content of the label -- they just haven't seen the final, printed version. This is not so significant as to cause the price drop today.