Replies to post #685222 on NorthWest Biotherapeutics Inc (NWBO)

[learningcurve2020]

It's good that the company explained all that to investors. Eye rolls.

[User-840664]

Any data on that? It's an interesting observation.

[The Danish Dude]

Sad for you then that DCVax-L was the first drug to get the UK PIM designation in 2014.

But don't worry. I will add what you missed, so people can get the full non-fudded narrative.

You're welcome 👍🏻

https://www.prnewswire.com/news-releases/nw-bios-cancer-vaccine-is-the-first-drug-to-be-designated-by-uk-authorities-as-a-promising-innovative-medicine-pim-275263351.html



https://www.gov.uk/government/news/first-uk-promising-innovative-medicine-designation-awarded

CHATGBT

No, the scenario for drugs receiving a Promising Innovative Medicine (PIM) designation is different from the "Specials" program. The PIM designation is part of the Early Access to Medicines Scheme (EAMS) in the UK, which aims to provide patients with faster access to drugs that do not yet have marketing approval but show promise in treating serious or life-threatening conditions. The PIM designation is a step within this scheme that signifies a medicine is a promising candidate for early use based on initial clinical data.

Drugs with PIM designation are indeed intended to go through further clinical development and regulatory review processes toward full marketing approval. The PIM designation facilitates earlier patient access during this development and review process. Thus, unlike the "Specials" program, the PIM scheme is designed as a pathway toward eventual marketing approval for new and innovative drugs, not simply to meet the unique needs of individual patients with existing drugs.

[User-840664]

Ex... Any truth to this? In your opinion.
“No matter what anybody says, NWBO cannot get approval until they run the pediatric trials. This is from the EMA - same rules apply MHRA

"All applications for marketing authorization for new medicines in the EU must include the results of studies as described in an agreed pediatric investigation plan, unless the medicine is exempt because of a deferral or waiver."
NWBO submitted a SAP for pediatric trials, which has been accepted. But until they run - or start to collect enough data to make a case - they are dead in the water. No matter what, they have to run pediatric trials .