Risk to Reward...
All 331 patients, including all control who either didn't receive the vaccine, or they received it late: mOS: 23.1 months from surgery.
Top 100 patients in the trial, including both methylated and unmethylated patients, their median OS (albeit KM derived) was 58.4 months as of a year ago, supporting the premise that there is an extremely long tail.
Almost 30% of the trial patients (28.2%) had reached 36 months survival, as of 11/18. On SOC, that amount is usually between 9 and 16%.
UK's NICE has been at-the-ready to appraise DCVax-L, something that rarely happens for a drug or treatment until AFTER FDA approval.
As Doc likes to point out, Fraunhofer had enrolled the number of patients into the trial that was "statistically necessary", leaving 17 out.
Those missing 17 patients represent the exact number missing from what was anticipated to be enrolled into the control arm, and would have brought the enrollment from 99 to 116 (348/3 = 116), bringing the trial number to the intended 348.
The treatment arm was fully enrolled (2:1 ratio / 116 x 2 = 232).
Kevin Duffy moves from position at Merck developing and commercializing Keytruda for 5 years, to NWBO. Keytruda was first approved in September 2014, so Duffy was in that position from the start.
Cognate poised to begin commercial manufacturing, and has received a statement of compliance for EU cGMP, a precursor to their ability to release product in the EU/UK.
Unblinding is close at hand, and could happen at any time.
SEC investigation in the rear view... so long as NWBO continues to mind their K's and Q's and SOX.
All lawsuits (6?) either thrown out, or settled for lawyers' fees.
For those that argue the company doesn't update us, there have been 8 PRs thus far this year, and extensive updates were given at the Annual Share Holders meeting in January, and at ASCO in June. I think the issue for many shareholders is that the updates don't include unblinded top line. But that is coming.
While they seem to be sliding along on very little money, there are plenty of investors ready to loan them funds, or buy bargain basement-priced shares in this company, telegraphing that whatever money is needed to get them over the home plate is available.
The company has strong long retail shareholder support.
There are plenty more risk to reward points to make, but these were the ones that seemed relevant now, and that came to my mind. I'm also not going to bother making the risk points as those who aren't invested make post those arguments a trillion times a day.
