Biotechnology News : FDA - SGEN by 9/14/13 POSTED.
The FDA is expected to take action on the application by September 14, 2013. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of HL and sALCL, that was granted accelerated approval by the FDA in August 2011 for relapsed HL and relapsed sALCL.
“Our goal is to broaden the ADCETRIS U.S. labeling claims to provide both patients and physicians the opportunity to incorporate ADCETRIS into additional HL and sALCL treatment settings,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “The FDA’s acceptance of our sBLA
submission is an important step towards making ADCETRIS available in the retreatment and extended duration setting, and we look forward to the regulatory outcome.”
SGEN July 31
"Received notification from the U.S. Food and Drug Administration (FDA) regarding the company’s supplemental Biologics License Application (sBLA). Based on ongoing interactions with the FDA, Seattle Genetics anticipates that the 16-cycle limitation on duration of use of ADCETRIS will be removed from the U.S. prescribing information. It is further anticipated that a label claim for retreatment will not be approved. Seattle Genetics intends to submit data on the use of ADCETRIS for retreatment to guidelines review committees for potential inclusion in compendia."
We have our answer to the BLA.
Something's not right with the recent posters pushing the FDA decision when the answer is well known. They're not what they seem. They're intent on pushing this hoping to a few unsuspecting investors. My guess is that they are already shorting.
The BLA became a non-issue with new FDA guidelines which allowed Re treatment. New data will change the compendia. The BLA is rejected. No big deal.
I'm neither long or short I have no position.
Watch out for these guys.
3 strikes your out. First you don't have a position, that's what all shorts say..lol you just come here and write paragraphs for no reason. 2nd. Every FDA Calender Says SGEN Sept 14th and The Government AND the FDA sites just forgot to remove the date..lol 3rd. Your July 31 st post says their anticipating the FDA decision which means it hasn't be announced but looks good. I post on stocktwits, usually never here but had to leave this.
July 31st Says SGEN "ANTICIPATES " that the 16-cycle limitation on duration of use of ADCETRIS will be removed. This is great news if removed but it has not been announced yet or official that is why it says "anticipates " Sept 14th will be official announcement and decision.