NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

If I remember correctly, CHM have schedules established for what they're reviewing. I don't believe any such review has been scheduled. If I'm wrong, let me know.

I don't doubt that the company and regulators have had substantial communications. I believe the regulators do intend to approve, so the question is, what are they approving. Have the discussions been about expanding the label, or have they been about the EDEN, or strictly an approval for GBM alone. Are they requiring a confirmational trial, and could it be the protocol for that trial that's taking so long.

If I were NWBO, I would want to be permitted the addition of Poly-ICLC and/or Keytruda with DCVax-L in a trial, whether it's considered confirmational, or not. The last thing I'd want to do is another monotherapy trial with what I know is possible with the addition of other therapeutics.

All I'm suggesting is that the company may be pushing hard to do things right. While approval is the key, if they had a chance at tumor agnostic, spent a few extra months trying to get there, but ultimately failed, I believe it was still worth the try. We'll really never know as the story will never be told. On the other hand, if they do get a tumor agnostic label, I think it's fair to believe it extended the time it took to get the yes.

Gary