Replies to post #684902 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

Poor Man -,

One obvious reason NWBO might have chosen to submit first with MHRA is that a cash strapped company needed to wait out guidance changes at FDA where big pharma has considerable influence. They might have also considered the promising innovative medicine (PIM) and National Priority designations as a sign that MHRA was ready to act favorably without the heavy influence of big pharma getting in the way. No designations like that in the states anywhere to be seen.
Linda understands leverage and big pharma has it with FDA, media and politicians. Consider that no politicians are openly talking about DCVax in the US and yet in the UK there are discussions about the need for brain tumor research, trials and other which leads to mentions of DCVax in those circles. The media has been almost dead silent about advances with DCVax development while Cambridge outlets and others have been talking about NWBO and Advent. MHRA is likely more influenced by high ranking clinicians like Dr Keyoumars Ashkan and advocacy groups than by big pharma. All in all there is a more favorable climate in the UK than in the USA. Linda will always start where she has a better chance to gain traction and a few years back she and others were able to be present with government officials at a health care meeting that I think Lykiri shared pictures of. I have never seen anything like that happen in the USA. Best wishes.

[sentiment_stocks]

Tbh… I’ve often wondered if some in the FDA recommended the company apply first with MHRA. An approval first with one of the world’s toughest regulators, the UK, would help give cover in the US should BP try to thwart an approval application here in the USA.

All my opinion.

[Smitty5150]

You have been here how long, and you are asking this question?

It all boils down to the UK Specials Program: DCVax has been available there for how many years? It is only logical that they would apply there first. NW and the MHRA have has many, many discussions about DCVax. They just dont approve a product for the Specials Program and forgot about it and just let the drug "run" with no updates or check-ins, analysis of patients treated, efficacy and related outcomes. We dont know the outcomes of such discusions but they has to be good if NW decided to submit the MAA. Guidance is always given by regulators in terms of the next steps. What did the MHRA tell NW? It is a easy question to answer.

But you knew all this before posting your stupid question and you are just trying to create doubt as too why NW chose the UK first. Like it was a bad move on Managements part. Hardly.