As some of you may know, I had a conversation with a fellow shareholder and David Haen with Dr. John Lee, M.D., SVP Clinical Affairs, NantKwest.
After asking when the NDA might be submitted I was told they have not even started the rolling submission because all of the data is not yet ready, and the database is not frozen. We were startled by this and the other shareholder asked, are you talking about the new natural killer cell + aldox combo or the SCLC or STS combo, or STS? Just to be sure we were told Q4 505(b)(2) Q4 2017. He repeated STS then mentioned it again explaining how much time was involved in the preparation and cost is involved in an NDA. There are no second chances on these NDA's with FDA. They have to make sure its done thoroughly and correctly, and specific mentioning of data analysis that is not even complete was made, including removal of statistical outliers and completion of the eventing of patients, and subgroup analysis etc, which can take 2 months.
Now David Haen says he didn't hear that, but I did. I have asked for written confirmation so shareholders can make an educated decision on their vote. If we are waiting for 18 months for a submission and another 6 for FDA approval, would people rather be on the Nasdaq or on the OTC? Its not my decision to vote for everyone, but I can see some people like a retired person that gets sick or a college student needing money to be on the nasdaq so they can sell without getting hammered.
I personally am very very long (*eye roll*) so I don't need to sell, in fact I will add more if and when this thing gets some kind of leadership that makes coherent sense and has a plan that seems feasible.
I don't know why everyone is freaking out, Patterson has said that Kriegsman told him 12 to 18 months several weeks ago. If I get the written confirmation I will post it, but I have requested that the companies issue a press release with that info.
SB
