Replies to post #312323 on NorthWest Biotherapeutics Inc (NWBO)

[marzan]

then wish the PR says something about the Fast Track they might have applied or FDA is reviewing something like that to grant. But I doubt they will say anything about FDA in their PR except 'Received approval from FDA' kind of news soon. MI Dendream reported Agios got some trial efficacy reviewing the IDH info and FDA is looking at it favorably. So, uploading IDH and imagings making sure done right could be contributing to some degree of FDA related news here. In any case like so many of us believe we got solid data. I am going to continue to be patience.

[flipper44]

I had to digest what you are saying. The benefit of fast track for NWBO would not be accelerated approval, because in the phase iii that ship has sailed, THAT SAID, the two benefits from fast track would be priority review and rolling review. They should have been able to approve FT by now if all’s well. You are probably right, in that it would be a multiplier impact for any positive TLD announcement. Here’s hoping.

[MI Dendream]

I don’t agree that there is any excuse for not hitting the September expectation. Yes, they couched their statement to have legal wiggle room should they fail, but they clearly and repeatedly set September as an expectation. Should they have other things brewing with regulators or partners, there is no reason to hold TLD up. Putting out multiple PRs with good news would serve to add multiple gains in SP.

I’m not whining here because I actually do expect they will release results in September and if they miss by a couple days, I won’t cry in my pillow. If they miss by weeks, however, I will lose confidence in management.