Shareholder Special Meeting - Summary
Meeting called to order at 13:30 EDT on April 27, 2018 at 1050 Connecticut Ave., NW, Washington, D.C.
Linda Powers, Les Goldman, Jerry Jasinowski, and Cofer Black present in the room, Dr. Navid Malik and Alton Boynton present on the phone, as well as Lisa Porter from Computer Share Trust Co., who is tabulating the votes.
511,950,155 shares eligible to vote, 380,124,221 shares present or by proxy (74.22%).
All three proposals passed.
They will file an 8K (3-4 days?) with the results.
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Post meeting informal questions (summarized and paraphrased):
Question re: publication of the data from last year:
The decision was made to publish the data from last year in a learned journal and it is a (frustratingly) long process. Submitted to publication October/November 2017 and it has been 6 months. Linda referred to the process taking 6-9 months on average at the ASM. They are, at least for now, staying the course and awaiting publication.
Question re: approval process:
This will be largely dependent on the data. There are accelerated pathways available and they are encouraged by the current regulatory environment. Right-to-try is looking promising.
Are they still collecting events?
Yes.
Do they have a count on the current number of patients alive?
No. They are doing the data collection now, in the early stages. This requires the staff of the CRO to physically visit each of the 80 centers and verify hardcopy records against the database and figure out the discrepancies. All of this is done by the CRO, not by NWBO.
Where do we go from here once data is collected?
What we want to see, and what investors want to see, is the full performance of the product. This is the only opportunity to see what the product is capable of. Many companies have unblinded too early and paid for it. Everyone wants to see the long tail.
Is data collection only an annual thing or could it be done more frequently?
It can be done more frequently but it is expensive, time-consuming, and hard on the sites. They are finding yearly collections to be sufficient. They have not ruled out doing one in the Fall.
Are patient deaths reported to them?
Patient deaths are reported to the CRO. The company only gets the data from the (currently) yearly data collection. The data collection includes patient deaths and all of the other data. Patient deaths are not very informative in and of themselves.
Question about ASCO presentation:
Can't answer anything about that. They are currently focused on getting publication of last year's data. They cannot combine it with this year's data for publication.
Questions re: what the FDA accepts as primary endpoints.
Linda is not the person to ask, that is more a technical matter. She does not see psuedo-progression as an obstacle to PFS or cross-over issues as an obstacle to OS. These are just part of the playing field and there are now methodologies to deal with determining pseudo-progression.
How long does unblinding take?
Unblinding and data-lock take longer than the data collection (which is around 12 weeks). Asked about 8-10 months, not that long.
Asked about anything that can be shared that has not been asked about?
There is lots of data on the website about trials and studies. Unfortunately, nothing they can share right now.
