SM,
That's what I felt, but Mike, who provided the UK site for announcing approvals made it sound like that's how the UK wants it done, and perhaps the company isn't notified until the UK update is about to occur. I really don't know and while I believe you could be right, no one else chimed in and said so. I feel quite certain that the FDA notifies the company on making a decision, and if not an approval might even discuss what needs to be done with the company in addition to the CRL, but I'm not sure of that. I suspect they might speak with the company if they're approving, but requiring a conformational trial. I believe the UK speaks with the companies as much or more than the FDA, but don't know what I think is true.
In the case of the FDA, I don't know how much has changed since the IMCL fiasco where Martha Steward and the CEO went to prison for insider trading. It was clear in that case that the FDA had corresponded about problems with the trial, but the company openly said things were going well with the FDA and achieved a partnership with BMY on that basis. I believe there is still far more discussion than we realize, but the FDA now will state if what's said about them is a misrepresentation of their position. At the time of the IMCL fiasco, the FDA was prevented from commenting on IMCL misrepresenting what they said.
We should know for certain in two months or less, it should be good times for NWBO investors.
Gary
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