Replies to post #44468 on NorthWest Biotherapeutics Inc (NWBO)

[dpinvest]

Amazing the confidence you have in pointing to a 127 patient phase 2, while the 4x larger phase 3, discussed at great length in the same "gotcha" document you link to, was successful at providing the four month statistically significant survival extension for ADVANCED prostate cancer. And the confidence as well you have at thinking one can ignore a $billion of expenses of DNDN just because they were debt financed, absolutely mind-boggling.

[exwannabe]

.. The first P3 [DNDN's Provenge] randomized 127 patients and the second (IMPACT) randomized 512. That's 639 patients buddy.

It was a little more complicated than that.

Initially they had 2 mid sized P3 trials 9901 and 9902. The first study, (9901, your listed N=127) completed and missed the primary endpoint on PFS. Based on results of that, DNDN decided to change the 9902 trial. But this would not be stat proper, so they split the enrolled patients into 9902A (I think that was your N=98) and an ongoing larger 9902B that they hoped to be registrational.

Then it turned out that the first study showed OS with P<.05 and DNDN had hopes for approving on that when combined with the upcoming '02A data. The 9902A results also came in "OKish", and DNDN whent to the FDA on those 2 trials. Adcom voted yes, FDA said no (thank God the adcom said yes, I cashed in a bunch on that pop).

With the CRL on that data, DNDN once more changed 9902B to become the Impact trial (N=512) with OS as the primary that garned the approval in 2012.

A fairly complicated regulatory history, but no mystery with the public as to what was going on. But Gold did conceal a manufacturing issue which alone was certain to cause a CRL in 2007.