Replies to post #423738 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

I would agree on RMAT. But I think they may not want to say anything if for any reason the FDA thinks it could be a giveaway on Project Orbis. I could be wrong.

[biosectinvestor]

Also, they do not need TLD to get RMAT, but manufacturing capacity, while not a requirement might be important to the FDA as any accelerated status will potentially put them in line to be the new standard of care.

[biosectinvestor]

I am sorry, what is the reference to BTD?

And yes, if you mean accelerated status, it is a requirement for Project Orbis that treatments being designated for the program have accelerated status, often gotten before now, and RMAT does not require final data be released.

Manufacturing IS very important for accelerated status, though not officially in some cases, but it presumes a treatment could become the standard of care. Companies need to have a practical plan, to the satisfaction of the regulator, not everything immediately in place. For Orbis, presumably this would suggest a global plan.

Really as for RMAT, it can be given based even on just very early data. It did not exist during most of the time that NWBO has had trials and is a fairly recent designation. I believe that they may want to hold back and either not announce or announce all at once or in succession. More likely though, IMHO manufacturing may still be the final point of clarification.

All above, IMHO.