Replies to post #693323 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

If I remember right someone here posted that in biz show it was said that only MHRA knows and decides when clock starts . So if they haven’t told the company. I doubt they will tell you .
Maybe ask them what has been improvement in time/days taken for approval this year

[QL300]

Validation
The assessment timetable for new active substances and biosimilar products or existing active substances will begin after the validation of the application.

https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines

[Red_Right_Hand]

I've emailed them simpler questions in the past and have waited weeks for a reply. I emailed them this question as well, but still haven't heard back. Somebody there will know the answer, but part of the delay in response will probably be them trying to figure out who it is that knows the answer.

[RobotDroid]

The idiots are running the asylum.

[JFR161162]

I suggest you email to Mrs Siobhain McDonagh.
Politicians are driving the show.

[Nemesis18]

I’m starting to wonder if they even know.

My guess is that the MAA decision has been taken out of the MHRA’s hand ☝️🤷🏻‍♂️

[mike00h]

500 years ago: "Did you ne'er hear say/Two may keep council, putting one away." -Shakespeare
250 years ago: 'Two people can keep a secret if one of them is dead.' - Ben Franklin
5 years ago: 'News is here when I see a large move up in heavy volume.' -Me
Oct, 2020 : 'Huh?' -Me
May, 2022 : ' What the ....???!! ' -Me

Now : Gritting my teeth.'

Hedge and dark money pools conduct industrial espionage on most BP companies in order to get an edge on announcements or other news that would affect stock price. Moreover, dark investment pools spy on, and try to influence the FDA.

To keep things interesting, big pharmacy also spends huge bucks to spy on and influence the FDA (approvals) as well as the US congress (Medicare) and medical practitioners (it's how they get a doctor to tell you about something they sell). BP is also direct to customer: Has anyone seen an advertisement for a prescription drug on TV lately? All your friends are going to love you after you start taking this. "Tell your doctor that you need it. Don't worry about those side effects. "

It's no wonder Americans see deep state and conspiracy everywhere. It's almost out in the open in the healthcare segment. Remember Martin Shkrelli? In an astonishing reversal, a crook totally exploited the deep state. I could quickly make a case in the telecom industry. Verizon and AT&T etc. want to charge for volume of data transferred rather than be common carries. The FCC are political appointees. Do you think they don't get lobbied (with the occasional attempted bribe?)

Some longs (-Me, and NWBO) are resting their hope on MHRA being a lot less compromised than the FDA. I'm up to my nostrils invested in NWBO, but there is that risk.

The bone in my throat? Last December we submitted an application. I expected approval by May 19 because

-Safety was proven in sanctioned trial (safety profile is similar to drinking water)
-Effecacy was proven in sanctioned trial ( first and only effective treatment.
-JAMA
-Nature
-RFI is ridiculous. This is new science. The staff at MHRA are not sufficiently qualified to ask meaningful questions...barely qualified to validate the application plus they know this works.)

Why is the timeline murky? I really believed that after December 20 last year, I could count on approval by May 19.

I can bear to wait a few more days.

The people who die every day may see things differently.