Replies to post #569472 on NorthWest Biotherapeutics Inc (NWBO)

[Poor Man -]

That’s why they call it..,

The Ex Files.

[ilovetech]

Flipp - Imo, the reason is three fold.
- The unprecedented nature of this undertaking has proven to be time dynamic for reason anything associated with "first" makes predictions impossible. Secondly, the company is shell shocked from attacks over the years, and decided on a less is more approach. Offering more material only begets an interest for more. Shills use any meat to twist and obfuscate benign information into something that gives life to a complete falsism.
- Keeping it simple stupid allows everyone in the company to have the same information at their tongue's edge, so when shareholders or media engage any staff potentially, something that shouldn't have been disclosed isn't inadvertently.

ILT

[dennisdave]

What I think is going on is that NWBO management decided to pour all NWBO available resources into getting Advent ready first and had little or no resources left to apply for MAA. So LPs remark was more her policy than the MHRA.

I hope the MHRA will not allow MIA to be granted as long as the request for MAA is not submitted, forcing LP to submit a request for MAA. I hope the MHRA will stop the can-kicking, something that NWBO shareholders, BOD, MD's, bad press, were not able or not willing to do.

[Know-Fear]

How much is intent, ineptitude and intellect (intelligence gathering/learning/understanding/optimization)?…..major league tea leaf reading

[dennisdave]

After reading Notes for applicants and holders of a Manufacturer’s Licence its clear to me that applying for MIA only applies to products that have been Marketing approved.

For the manufacture or assembly of unlicensed medicinal products which are exempt
from marketing authorisation requirements (“specials”) the appropriate authorisation is a
Manufacturer’s “Specials” Licence. In other words, and this is read clearly, MIA and MAA are intertwined. Its also clear from the document that the holder of the MAA product is subject to inspection as much as the MIA location and staff.

The Human Medicines Regulation 2012 gives powers to the Licensing Authority to carry out inspections at the premises of manufacturers of such materials, the marketing
authorisation (MA) holder and any laboratories employed by the MA holder.

and

A QP has a personal responsibility for ensuring that the required tests and controls are carried out and must sign or certify, for each batch, that the appropriate tests have been
carried out and that it complies with the relevant marketing authorisation (MA)

It does however not read anywhere in the document that MAA (submission) if the product is a prerequisite for obtaining MIA. I will ask this question one more time with the HMRA.