Northwest Biotherapeutics (NWBT), Bethesda, Maryland, U.S.A. developed the DCVax®-L vaccine which may now, under PIM status, be used as an adjunct to treat these aggressive brain tumours in patients in the U.K.
I do not believe that DCVax-L can be used at this point yet with "just" a PIM designation .... instead I believe that NWBO must apply for Step 2 (Scientific Opinion), and only after a positive opinion is used on Step 2 will DCVax-L become available for treatment in UK.
[quote]If this vaccine shows success in clinical trials, an application can be made for step two of the U.K. Early Access to Medicines Scheme (EAMS), and then on to formal medicines licensing. The future role of dendritic cell ‘vaccines’ provides an exciting development in ‘personalised’ immune therapy in oncology.
I do not believe that the vaccine "must show success in clinical trials" before NWBO can apply for Step 2. I believe that NWBO can make this application at any time. I wonder why they have not applied yet. Regarding "and then on to formal medicines licensing": instead I believe that upon receiving positive outcome from Step 2, that then the treatments can commence immediately. And that somehow, at some time, the payment for such treatments will need to be worked out. I am still unclear on how that may take place and when.
I am considering sending the author a reply, or adding a comment to the article. Before I do so ... can you guys confirm that you agree with my above understanding regarding these 2 issues?
