NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

Of note in the trial PFS and OS times are estimated from time-point of randomization, which happens approximately three months after initial surgery, whereas in common clinical practice these are usually calculated from the time of surgery.

As we've discussed many times, the above fact is important to note. Also note, as also stated many times, it takes 3 months to actually enroll in the trial.

This abstract came out (November 2014) after the trial enhancements (August 2014). And as you stated...

In case the primary and secondary endpoints are not achieved, it is planned for the data to be analyzed further based on sub-classification of the trial population. Finally, three interim analyses have been scheduled to take place for data evaluation while the trial is ongoing.

I wonder if that changed from the April 2013 protocol as I don't recall a mention of that analysis in it. Plus... the three interim analyses doesn't jive with the two... unless the third is really the data analysis at the end of the trial? Or are did they add the safety review of the 66 patients as the 1st IA?

Final approval of DCVax®-L will await the outcome of the phase III trial although if interim analysis results are favorable, then an early approval of the product may well be achieved.

Hmmm..

If the results of the trial translate into approval of the product, then demand is likely to be a significant consideration. Therefore an international network of manufacturing sites will be required to enhance NWBT's infrastructure and ensure its capacity to address this demand. Another issue to consider is the manufacturing costs. With the increasing demand, it is likely that the costs will be reduced, but since DCVax®-L could potentially monopolize the market for a significant amount of time, a discussion with the international health systems and funders is required to ensure accessibility of the product to the patients.

Double hmmm..

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4514134/