Replies to post #605113 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

I think I agree with this. They absolutely could be in RR I’m not denying that in the slightest.

Not sure about it being “likely” that “nearly almost all” of the components of submission were accepted prior to March 20. If that were the case I find it very hard to believe that a fully accepted MAA has not been announced by now, over 3 months later. It’s possible, again, I’m not omnipotent and I certainly can’t find any evidence that guarantees a rolling review was not “nearly almost all” completed by Mar 20. Maybe they just paused for 3 months before hitting the submit button to double check their work.

Regardless, that’s opinion and I’m not arguing against that. If you go back to the beginning of the thread, the claim I’m responding to was that the MAA had to be accepted prior to the issuing of the MIA cert, and that means an approval decision can be expected around the order of early July. Which I very much disagree with.

[MrCuriosity]

I thought that NWBO already received the approval of MIA about 3 months ago according to their PR.

It is absolutely frustrating not only for patients who urgently need such an approved treatment, but also for investors to wait an awfully long time!

I hate blaming the NWBO management, but they need to get their act together to speed this up.

You are right that continents move faster!

[antihama]

Lykiri's post indicated that MIA and MAA are independent of each other; I'm assuming you're referencing the post from Richard Parker, Senior GMDP Inspector MHRA.

You are correct that a facility manufacturing an ATMP must have a current GMP Certificate to manufacture either an IMP(material for clinical trials) or an MA product.

If the facility is in the UK or EU it must also hold either a Manufacture Import Authorisation MIA or a Manufacture Import Authorisation for Investigational Medicinal Products MIA(IMP) depending on what product is being manufactured. If in the UK the facility/company must apply to the MHRA for an MIA or MIA(IMP) and this process could take 90 days, during which time an inspection will also be carried out at the facility. Depending on the time taken to close out the inspection and issue the GMP certificate/s this may be longer than 90 days especially if there are any issues found at the inspection. This application can be made at the same time as the MA application so long as there is an intention to manufacture product at the manufacturing site. However, it should be noted that the processes are independent of one another and an MIA and or GMP Certificate must be in place for the manufacturing facility before the Marketing Authorisation can be granted.

And Fe previously noted the MIA approval PR indicated that the MAA was not submitted

Linda Powers, CEO of NW Bio, commented, "We are very excited to reach this major milestone, as it is an essential step towards submission of our application for regulatory approval of our lead product, DCVax®-L. It is especially exciting to be able to operate globally from this base in the U.K."

So I'm not seeing what you're seeing but we are all taking a stab at it w/o any real guidance.