Replies to post #743536 on NorthWest Biotherapeutics Inc (NWBO)

[martyDg]

I couldn't agree more with your statement.

[learningcurve2020]

Therefor it’s very likely Specials in not showing any real impact, as I suspected.

“The compassionate use program has been in place long enough to show its impact on patients”

[manibiotech]

Of course they are 
But this information was not hidden or a secret before deciding where to apply and when and when to submit evidence to NICE
Think about how many years ago the last patient was enrolled and treated 

[JTORENCE]

All the result of the greedy CEO wanting to go for it without the expertise and $$$$ of a BP. How the f--k does she sleep at night? imo

[iclight]

The company decided to submit the the MHRA, not the FDA. Not that they had a choice. The MHRA won't give a crap about the minimal compassionate use cases given they have 331 in the actual trial. They will give a crap about no patient level data in the convoluted control arm which is probably why this is sitting without movement. An RFI to which the company hasn't responded.

[exwannabe]

The compassionate use program has been in place long enough to show its impact on patients.

How can they possibly leverage the Specials program?

Though being called compassionate access, the program is basically for patients that have a special need and therefore the drug (and formulation) they need is not worth it for any company to take through approval because there is not a sufficient market. The classic case is a formulation that changes the non active ingredients to avoid allergic reactions.

This MHRA FAQ states clearly the Specials program is NOT for drugs in the approval process .

1.6 The exemption and this guidance does not apply to other unlicensed medicinal products, for example:
...
investigational medicinal products

NWBO gets away with bending these rules by claiming what is being provided in Specials is NOT mercidencel. That makes using that data a bit difficult.

[RobotDroid]

Most likely its not their fault, it's the flawed submission that is causing the delay, and the silence out of linda worthless about the errors they made.