NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

Lykiri,

The wording "statistically necessary" describing recruitment instead of saying enrollment was completed is a hint on their part in my view that they did not fully enroll. They also did not say what month their enrollment ended only the year recruitment ended. Their enrollment started after August 2014 based on their batch making claims but their recruitment and enrollment ending months were left unspecified.

Another key take away is captured in that same quote and that is ".. thus successfully completing the manufacturing and testing activities at Fraunhofer IZI." Note that they didn't just say "completing" but rather they said "successfully completing" the activities in 2015. Just as a reminder, that happened when a voluntary hold was initiated there. How could a voluntary hold occur and still result in a "statistically necessary" level of patients being recruited but not necessarily enrolled and successful completion of manufacturing and testing activities. On the one hand you have a hold and on the other you have reached a level of statistical need and manufacturing testing success in spite of it.

What should be noted here is that the number of patients statistically necessary to prove statistical significance drops in proportion to treatment effectiveness. So when saying "statistically necessary" they are talking about the number of patients needed to prove effect not necessarily the total number of patients originally planned for enrollment to prove what might have been a lesser planned for effect. Now in some circles recruitment and enrollment evidently mean the same thing but I would doubt that is the case here.

Now if I may be so bold, let me straighten out this path a little. A voluntary hold was placed on enrollment in Germany by August of 2015 but in spite of this the statistical necessities for the trial there were taken care of and manufacturing and testing activities were successfully completed. Seems like what looked like it could be a bad thing might have turned out to be pretty good. Best wishes