Replies to post #285175 on NorthWest Biotherapeutics Inc (NWBO)

[spartex]

Thanks! Why wouldn't the U.S. approve first, more paperwork and regulatory review than U.K.?

[sukus]

Thanks Umibe.

[biosectinvestor]

I am not surprised by anything you’ve written there but I always thought this seemed obvious to me on its face though difficult to assert from our far off position as just observers:

“He did say that the FDA reg guidelines were, in his opinion, a "four corners" response to NWBO's SAP and appeared as a public yet direct response with this SAP in mind. In his opinion, this is "huge" for NWBO. He did say that both Hahn and Pazdur were supportive and eagerly awaiting the results.”

That change in guidance seemed custom made to me as well, from the moment I read it. That jumped out at me.

[erik007tc]

Very encouraging, great info. Thank you!

[sukus]

I read it again. Excellent post. Hope wolves would read this post first before they embark on shorting. If not careful they would be whiplashed by robust long and fat tails.

[vator]

Thanks for the input.

[longfellow95]

Umibe. Thankyou for feeding back from your conversation.

'FWIW'.
That indeed is the issue.

LG appears to be suggesting that there may have been no feedback to a draft SAP.
But at the same time, he also appears to be suggesting that the new draft FDA guidelines somehow were a direct response to NWBO's SAP, or otherwise tailored for DCVax!
Is this at all credible?
Not for me.
I have no idea what 'four corners' means.
(A rectangle?!)

We already know that the tail is long and quite fat. Les will no doubt have more up to date blinded data than us that further confirms this.
But we don't know anything about delta and nor does he.
So how does he know the results are 'so good'?

He may end up being right that the UK approves first.
But at the moment, nothing is clear about the UK regulatory scene, given that we are in the middle of the Brexit transitional year.
If NWBO were submitting a marketing approval application right now, it would go to the EMA and not the MHRA, and be subject to standard timelines (be they the accelerated standard timelines or the standard standard timelines).

So while his remarks are not discouraging, right now I can only really take this as a piece of 'Les speak', with its characteristic hyperbole.
In terms of how it might translate into positive outcomes, I will take it with a very large grain of salt.