News Focus
News Focus
icon url

learningcurve2020

08/02/24 11:15 AM

#710201 RE: Dan88 #710197

That's weak. Scheduled by who NWBO or MHRA?
icon url

Zadie420

08/02/24 11:19 AM

#710208 RE: Dan88 #710197

Dan- The question is why US? Does US facility is going to support making DCVax-L? I understand about UK.

I think we are very close now they have scheduled the inspection.
icon url

ROS-CH

08/02/24 11:23 AM

#710213 RE: Dan88 #710197

Well, the more important part of this sentence IMO is :

" including preparations for inspections by the MHRA that are scheduled to take place in both the US and UK "
It says not the inspections are scheduled, but the preps are underway.

Another 3-6 months ?
Bullish
Bullish
icon url

Nemesis18

08/02/24 11:23 AM

#710214 RE: Dan88 #710197

>>>>01, "Meanwhile, we are continuing to focus on working with our teams of consultants on activities related to the review by the Medicines and Healthcare Products Regulatory Agency (MHRA) of our Marketing Authorization Application (MAA) in the UK<<<




So basically, there was clearly a RFI as the NWBO's Consultants are having to address the issues raised, after the initial review of the MAA Application.
It is exactly as I stated, that the application clock had been stopped, and that ithe review process had derailed.

Also that Les said the 'Fall', as he was reacting to information received from the MHRA
icon url

flipper44

08/02/24 11:29 AM

#710221 RE: Dan88 #710197

“Scheduled”


I agree. That was the most important word from the release.

“Associated”



The second most important word.
icon url

JTORENCE

08/02/24 11:43 AM

#710235 RE: Dan88 #710197

Dan88 KEY WORDS: INSPECTIONS ARE SCHEDULED! IT MEANS THEY WILL HAPPEN IN NEAR FUTURE- that statement is pure speculation.