Bericht op Yahoo board, van een "Insider".
De man riskeert een veroordeling.
I work with the FDA, everyday...
I know because I have presented and won approval for Biogen - Idec for Liquid Avonex and a few other small molecule and large iGg's. If there is a weather delay, it's the truth. Some on the panel may have not even been present for work today due to the clean up. They need a full day and the regulatory staff for Chelsea is there, right now to answer the questions and explain the benefits and safety, verbally.
Now personally, I believe Northera wins approval because I am a data mining expert and I saw the data and it's solid, this time. All the holes have been filled. The safety issues are moot, nothing to speak of adverse enough to raise eyebrows. The panel recommend vote was substantial. I really can't see anything getting in the way of approval. Nothing.
The only hang up may be a continue post market approval contigency to show more efficacy and safety data. If labeling is brought up, then there may be another delay, but abeit a small one. Like I said I know how the FDA thinks and it's all about numbers. The more you have and the larger the pile which shows benefit the greater the chances of success. Northera has an eCTD submission the size of Mt. Everest. I can guarantee you the FDA just went over the summary portions and a few pages to audit for consistency. If nothing was found they are on the hook and then it's just up to the Corp., Reg's to do their talking to answer questions about future CMC's, etc.
Again, i speak from extensive 24 year experience going back to Sepracor days. I have seen it all.
I would bet the farm on this one. Easily.