Over-thinking confuses and ultimately kills anything on its tacks!
In Summer 2015, there was a planned interim analysis. As a result, DMC disbanded and Linda has since headed on a long road of regulatory pursuit for changing the primary endpoint from PFS to OS, all due to the messed up PFS data because of pseudo-progressing.
Nobody knows and can be ascertain that PFS data would be eventually adjudicated correctly and nobody knows FDA would look at nwbo in the future with a change of smile.
Soon, FDA refused Linda's request for endpoint change (the regulatory pursuit has been ongoing until a certain point, maybe when FDA lifted the partial halt). What happened next is the revelation of the partial halt for new screening -- the stock price collapsed and has never recover since. There have been endless dilutions!
If nwbo were a big P, it will be highly likely FDA would approve the endpoint change, since OS is the golden standard and it is still today and will be in the future.
So the reason for the partial halt could not be disclosed at that time and it continues, which could only be disclosed (and nobody will really care), if topline data is released and it's positive.
So it's as clear as day that the only way for nwbo to exist as a successful company for years to come is to extend the trial as long as possible to catch the long tail -- a significant large number of patients (20 - 25 %) will live a long term, about and above five years, in a manner of statistically significance -- no companies, big or small have never ever approved a big fat long tail with the actual years and days patients have lived in the history! We are close to that revelation.
Nonetheless PFS is still the Primary Endpoint and OS is still the Secondary Endpoint. Although if the long tail exists and it is statistically significant, meaning there are clear separations between the some comparable groups, and FDA will have to approve the vaccine because of that, the best interest for the company is that PFS endpoint is better approved statistically significant. Besides, nobody can guarantee that the long tail will be a clear cut without unblinding.
All these have hinged on the SAP saga we have all experienced for so long! Despite that, I don't think the company will stretch any more longer as long as it receives the initial responses from four RAs; even if no response from say FDA, the company is ready to lock the data, unblind, analyze and publish topline data in the near future, by end of this year or the latest early next year. All my bet is on this, and I have bought a lot of more shares recently.
With regards to the Q report: it tells us, the SAP draft was completed in the quarter (any day from July through September 2019), and the data scrubbing was almost complete with only "a small number" outstanding from a few hundreds of queries as we knew from the last time it was mentioned -- A small number, a few queries remains back before the end of September meaning database lock is ready at any time!
Also bear in mind there are usually three factors a successful biotech company must have:
1) we have a quality product (DCVax-L, suggested long tail without side effects) with real-world demands (in our case for GBM patients) -- this is the first thing a successful biotech company must have;
2) we also have quality and accessible advisory board and committee (Linda is smart enough to use the experts opinions in a continued base) -- this is the second thing a successful biotech company must have; and
3) A good relation with FDA -- this is the third thing a successful biotech company must have, which we are not sure at this point, but I do understand why Linda has traded anything and everything FDA so carefully.
As for my investment in this company, the only part I don't like is the repeated dilutions of shares, and I am dumb enough to repeatedly add more shares, but I can only look in the future, and it will be bright!
(I have no interests to post further).
AI
