I have taken a long position yesterday and have a question with Biotech Gurus. If NAVB files this with FDA by december end as stated earlier, how long this process may take to get approval on a fast track designation basis?
So with a lot of help from the NAVB MB, I have learned that the 60 days is on the request for Fast Track status. The FDA targets 60 days to respond to this Fast Track request. If granted, and LS was granted Fast Track Status, then the approval target time line is 6 months from submission. So if we submit the sNDA this month, we should see an approval (chance for denial but small chance IMO) in June 2014 +/- a month but most likely in late June or early July.
Thanks to Insideoutside and Fall on the NAVB MB. Good information. FUI to all longs!!
Ok, I guess I am a little confused. The announcement stated that the FDA had GRANTED FastTrack to NAVB. So now we just wait to see if lympho is approved for more indications. It is my understanding that we are no longer waiting for the FDA to review the FastTrack.
Still the question on what they apply for on the labeling. We know for sure they will apply for H&N and likely they will apply for something around SNL (labeling or language). I hope they take another pass at ILM but we will see in the weeks to come what they apply for with the sNDA submission.
I am hoping their strategy it to get H&N with SNL and ILM. Then going forward they do research cancer specific to add more statistics on cancer specifics. Then they can sell ILM in all lymph node procedures but only talk cancer specific for BC, M, and soon H&N. Then as they get more cancer specific added they can add the cancers and talk to them specifically but still talk generally to LS capability for SNL and ILM. That I think makes since as a strategy and that is what I hope they intend to do. We shall see. GLTLs
So May 2014 to July 2014 would be the expected window for approval.
It will be interesting to see exactly what the sNDA application is..... meaning applying for a labeling for 1.) H&N only, 2.) H&N with SNL language, 3.) H&N and SNL (not just language), 4.) H&N and ILM/GLM with SNL language, or 5.) H&N and ILM/GLM and SNL (not just language).
To me, this is what will be interesting because whatever it is has been thoroughly discussed with the FDA since the are getting it Fast Tracked which means it is highly highly likely to be approved. If it is numbers 3, 4, or 5 that is applied for we should see a nice pop since that expands the labeling to all cancers. If it is just 1 or 2 the PPS will be less impacted. It is likely 1 or 2 but we shall see!!