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Wednesday, May 27, 2020 5:41:34 AM
'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.
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