NorthWest Biotherapeutics Inc (NWBO)

[Dan88]

It's ignorant or disingenuous for anyone who brings DNDN's Provenge as a case for caution over FDA's approval decision in regard to PFS.

Simply put, if DNDN were faced with FDA decision today with its first phase III trial results, Provenge would be easily approved, unlike in the actuality about 10 years ago that it was refused for approval and the company was asked to have second P3 trial as confirmation for OS.

How come? Provenge at that time was surrounded with safety concern as a first cancer treatment vaccine ever put on FDA's table for decision in history so the concern over its safety might be genuine, but it was outrageously exacerbated by shorts.

So with safety concern and a slightly efficacy, FDA at that time was reluctant to approval Provenge.

Today, if anything has been proven and it is even agreed by shorts is cancer treatment vaccines like DC based is safe, very safe.

So it's not comparable whatever even if there were not separations in term of PFS.

In today's knowledge and environment, FDA will approve DCVax-L in all cases below:

1) "Failed" PFS, but successful OS;
2) Successful PFS, but "failed" OS;
3) a thick long tail alone;
4) Both successful PFS and OS;

others?