Replies to post #710815 on NorthWest Biotherapeutics Inc (NWBO)

[StonkMaster]

Interesting, thanks.

If validation started in January then they're behind schedule, it's been 194 days since January 24th.

Either way, hoping for a decision soon.

[XMaster2023]

Not much time to cover. The price should start to drifting upward.

[kabunushi]

The tracking sounds very good but remember on the CC Linda said she didn't even know for certain that they were in the 150-day program! Probably she was just being cautionary. Having the site inspections scheduled is a BFD. I wonder how many sites they will inspect and how many teams they have working in parallel. I don't think they cover more than a small number of sites for spot-checking rather than an exhaustive audit. Just a wild ass guess but maybe they'll take a month to complete the inspections. Hopefully not find anything to complain about. We know that NW has made major efforts to ensure the sites are prepared. It's a matter of every site being super well organized.

When I worked at IBM we were subjected to an ISO 9002 audit because the ISO certification had become required to sell our product in the EU. It took an insane amount of preparation to ensure that every single work procedure was accurately documented and all the associated documents for every person's job were online and immediately retrievable. The audit was very thorough but went quite smoothly because everybody in our organization was very well prepared. I'm sure it's much more difficult for NW because they need for all of the participating sites to be equally prepared and it's not their own people. But medical record keeping in the hospitals is supposed to be complete and airtight anyway. However, things still have happened like operating on the wrong arm or leg. LOL even though it's not at all funny if it happened to me.

[ae kusterer]

Hyperopia: when would you expect NICE approval post MAA approval?

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174864671


The RegulatoryConnect portal will provide greater transparency and visibility for regulatory assessments to industry. The functionality will let industry users log in using existing MHRA submission credentials and access RegulatoryConnect, where they will be able to:

* Use the Applications page to track the status of an application and see which stage it is at.

* Use the Current Granted View page to view live authorisation details, including status, key data and documents held against existing licences.

These services are available to those making applications to the MHRA on behalf of their organisation as an administrator or user.

Future functionality and features will be added to RegulatoryConnect later in the year, including the ability to submit applications and variations to the MHRA through the service.

https://www.gov.uk/guidance/regulatoryconnect


RegulatoryConnect guidance

Navigating the RegulatoryConnect portal
Published March 2024
https://assets.publishing.service.gov.uk/media/65fc55b8a6c0f70011ef91db/RegulatoryConnect_-_Navigating_the_RegulatoryConnect_portal.pdf


Understanding application statuses
Published March 2024
https://assets.publishing.service.gov.uk/media/65fc55b865ca2f00117da815/RegulatoryConnect_-_Understanding_application_statuses.pdf

[JTORENCE]

hyperopia "Because Linda and Les are in the perfect position to know. They have been overseeing the responses to the MHRA’s questions about the application, they understand how each phase of the assessment works, and approximately where the MHRA is in the review process."

Now that's supposed to be comforting. Isn't Les the over the hill guy who stumbled thru the radio interview(ala Biden) a while back.