Appreciate your insight on FDA and advisory committees.
Indeed everything is in place and in motion now. Tracks a rumbling. Blockbuster results are being delivered on a freight train, moving with unstoppable momentum. My only hope is for retail to own as big a portion as possible because this is the one.
One thing we can be sure of is the FDA has seen trial data and if they did not like the data they would have stopped/warned NWBO from proceeding with the compassionate treatment as what they are doing now, full steam ahead.
What signal would the FDA, UK/EMA give if they later this year would dismiss DCVAX L to patients that have been treated.
I agree with you MI Dendream. The FDA will not request or require an Advisory Committee for DCVax-L approval in the US. The DCVax-L safety data is unquestioned, and the DCVax-L efficacy data will be spectacular and overwhelming.
This will translate into a very quick FDA approval of DCVax-L in the US, once a complete BLA is submitted to the FDA.
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