Friday, May 21, 2021 4:30:30 PM
Everything you're saying about the company may be true, but I believe that what you're saying doesn't apply to Dr. Liau and the highly qualified clinicians who'd be working with her on either a paper for a Journal or presentation for peer review. While I'm sure there is some financial arrangement that covers cost, she and those working with her are highly regarded professionals.
Whether the company is headed for buyout, partnership, or will go it alone, I feel very certain that what it presents for peer review will be of the highest quality, and done in a timely way. I cannot say if these clinicians are also involved in preparation of the BLA etc. but I do believe the company contracts with very capable people.
I have no doubt in my mind that the FDA favors BP over tiny Biotech's, so partnering prior to BLA submission is desirable, but certainly not mandatory. A buyout is essentially game over for investors, our only decision may be, do we cash out or take stock in the buyer. I certainly prefer a BP equity partnership as I believe long term that will be most valuable. Either way, if such action occurs before approval it increases the likelihood of an approval without delay from the FDA, I believe the approvals in Europe are essentially in the bag, and could come this year if the BLA submission is completed before the end of the third quarter. Our FDA may take under the 6 months it's allowed, but rarely cuts the time by more than a few weeks. While I believe we may have rolling BLA's with all the regulators, I'd be surprised if the complete submission could come before the third quarter.
Gary
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