Replies to post #796836 on NorthWest Biotherapeutics Inc (NWBO)

[seekinganswers]

The answer is that nobody knows because the MHRA cannot comment on a pending application and NWBO who certainly can comment, refuses to do so.
That being said, the phase 3 trial was flawed in my opinion, and the supposed results/efficacy are in question, otherwise a decision would already have been rendered.
It's not Big Pharma because DCVax is used only as an addition to current standard of care and would not affect current treatments being also used.
My opinion, and the opinion of many scientists is that a new confirmatory trial will be required.
Who knows, just my opinion. GL.

[RRP60]

Dans, your guess is as good as anybody's about holdup. No one really knows except mhra. We are all patiently waiting for our miracle drug to come to market. Till then, this is a meeting place for exchanging optimism( coined by chiug) or to play with paid nellies ( if you dont put them on ignore). 

[jesster64]

Dansvans, just go back and read a years worth of posts(guesses) on what's the holdup. Some of the more popular theories being tossed about are they expanded submission to be for all cancer tumors, corruption , BP influence, inadequate submission paper, waiting for manufacturing to catch up for demand, waiting on new legislation to streamline approval, questions about treatment are slowly answered, etc..
Personally' I believe the MHRA is being extra thorough. Your guess is as good as any.

[Rising_Sun]

The MHRA (the UK’s drug watchdog) is totally in bed with Big Pharma—probably swapping staff and favors left and right.
The people reviewing DCVax-L don’t seem to care.
I bet they’re not even putting in a full day’s work to get this life-saving cancer vaccine approved fast. Otherwise, it doesn't make sense on such delays.
Meanwhile, brain-cancer patients are dying.

Picture this: you work at the MHRA and make £100,000 a year.
Some shady guy connected to a giant drug company slides you £1 million in secret to “take it easy” and slow the review by just 20%.
You’ve got rent, kids, and Christmas presents to buy—and this drug doesn’t affect anyone you know.
What do you say?
DCVax-L could wreck billions in profits for the big boys who sell pricey, barely-better cancer drugs.
So they whisper in ears, pay “consultants,” and suddenly the little guy’s miracle treatment gets stuck in red tape forever.

Without hard proof of corruption, I can’t explain these endless, inexplicable delays any other way.
The pattern fits too neatly: revolutionary therapies from small biotechs get buried in bureaucracy, while Big Pharma’s me-too drugs sail through.
Coincidence? Or conspiracy? You decide.

Oh, yeah. FCK MHRA. FU MHRA.

[MarauderWarlock33]

Ask yourself a question who would know best when to expect the MAA might come from the MHRA other than themself. It's got to be the company and LP - they are working together with MHRA to finalize the labelling which should be the last check item before SMPC write up by the MHRA. When LP gave us 90 days lead time for AventBio payment, she based the starting point from the agreement of sale's date and was telegraphing that the SMPC would take between 60 to 90 days max. LP is expecting the MAA to be delivered by the latest NOV. 27, 2025, Thanksgiving Day. Later when the actual signing of the sales contract of AventBio, she set the revised starting point of the 90s lead time out to that day. LP has lawyer back ground and I believe she wouldn't make this kind of rookie mistake - to me it was deliberate signaling to all suffering longs. Just thinking out aloud.