Replies to post #664096 on NorthWest Biotherapeutics Inc (NWBO)

[StonkMaster]

Nicely surmised Flip. Hope this is true.

[User-840664]

That's a nice story... nothing could be further from the truth though

[meirluc]

Hope you are right Flipper on the SWIFT program and NWBO's MAA being
a pioneer beneficiary. Come to think of it, if I m not mistaken, some time ago
Dr. Ashkan mentioned that once the MAA is filed, it would only take a couple of
months for that MAA to receive MHRA approval.

If Dr. Ashkan indeed expressed that opinion, was it based on hope or exuberance
or on solid information?

[StonkMaster]

Flip, can you share the link where it outlines SWIFT and specifically mentions the 60 day timeline?

Thanks!

[learningcurve2020]

I'm starting to think SNAIL is involved here or maybe even NOWHERE is close to getting involved too??

[iclight]

The only “program” NWBO is a pilot for is the “fleece shareholders for 2 CDMOs” program.

NWBO is a crappy penny stock that if it thought it had a legit shot at approval anywhere it would have submitted the BLA to the FDA shortly after datalock 3 1/2 years ago.

[Lykiri]

I think it’s possible MHRA had an Oncology Expert Working Group advising NWBO prior to submission.

I really didn't and don't think MHRA wants DCVax-l to hit bumps once NWBO submitted their maa. Therefore setbacks, if any, were to occur before submission.

I think SWIFT, motivated by cancer vaccine type technology (“high impact”), oncology working groups and veteran special teams assigned upon submission will get this done at lightening speed.

MHRA still has some of the best and most qualified regulator professionals on the planet. Their restructuring post Brexit wasn’t going to slow the UK down for long. Now, imo, patients will soon reap the benefits.

I agree flipper44.

This is a quote from Dr. Laura Squire-Chief Officer – UK MHRA

UK Regulatory Update – 26 September 2023

International Recognition

“From 2024, MHRA will move to a different model which allow rapid, often near automatic sign-off for medicines and technologies already approved by trusted regulators in other parts of the world such as the United States, Europe or Japan.

At the same time from next year they will set up a swift new approval process for the most cutting edge medicines and devices to ensure the UK becomes a global centre for their development.”

Dr. Laura Squire
https://www.gov.uk/government/news/mhras-new-chief-healthcare-quality-and-access-officer-begins-important-role