NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

I’d of course have to take exception to you labeling NWBO management as idiots if they don’t file for the MAA by 30 days. This whole 30 day rule thing has been an interesting rabbit hole to go down, but no where is there some sort of real rule stating that this is the timeline that must be followed… that one first files an MIA and 30 days later, they file an MAA.

This GOV.UK link indicates that to “QUALIFY” for a manufacture license you have to show MHRA that you “CAN” make the product.

https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences

Manufacturer licence
To make, assemble or import human medicines, you need a manufacturer licence, issued by the Medicines and Healthcare Products Regulatory Agency (MHRA).

To qualify for a manufacturer licence you need to show MHRA that you comply with EU good manufacturing practice (GMP) and pass regular GMP inspections of your site.

Where in that above cited directive does it suggest any hard timeframe whereby you have to file either of these applications? If there was a stringent timeline rule, logically, it would need to be listed in that GOV.UK passage.

In other words, the company can apply when they are ready to apply, but they can’t “qualify” until they receive MIA approval. And that’s it. There is certainly no set-in-stone linkable 30 day rule. And it’s very clear that if you qualify, the MAA license will be granted after the MIA is granted. In fact, this entire process, while linear to each application (MIA and MAA), it is also circular in that the MIA WILL NOT be granted until the MAA “is in the process of being approved.” Cited below from the same link:

Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.

And so, IMO, I fear that you’re setting yourself (and possibly others) up for a possible unnecessary disappointment if 30 days (August 6) after the last company PR was issued (announcing their license for commercial manufacturing had been filed - the MIA), a following PR is not forthcoming announcing that an MAA has been filed. I am not suggesting in any way that an MAA announcement will not occur within this timeframe (as I don’t know when they will announce they filed this application) I’m simply stating it would be unfortunate if you were disappointed if it doesn’t occur by then; especially as you seem to be inferring (by calling them idiots) that if the company hasn’t filed the MAA application by then, there must be some sort of a problem.

My travels on this 30 day rule topic are just not taking me where the UK links seem to be taking you.

All of these machinations of the MHRA timelines should be seen as no more, IMO, then querying exercises based merely on some cobbled together assumptions. And assumptions are of course, not facts.

I think this is very important. I’d hate to see your (and other’s) bullish attitude turn angry and irritated if by August 6, there is not a company announcement that an MAA has been filed.

Please instead consider that the company knows (better than all us i-hubbers) exactly when the appropriate time is to file the MAA for DCVax-L.