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Re: None

Wednesday, 05/13/2020 1:09:17 PM

Wednesday, May 13, 2020 1:09:17 PM

Post# of 705599
Almost no trial is perfect, and our trial will not be the exception. Much has been learned over the more than a decade the trial has been run and if you were doing it again, it would be done very differently. That doesn't mean it's a failure, only that it's imperfect.

When TLD are revealed, I believe investors will be thrilled with the results, and it will be shown in the price. Shorts will point to any flaws, and in reality you never know how the FDA or other regulators will react, so nothing is certain. I believe the many survivors that are announced will be why the vaccine should be approved, but when it comes to the FDA, nothing is certain.

Between TLD and approval there is usually a period of 9 to 18 months before regulator actions are taken. It takes at least a few months to prepare the BLA for submission to the regulators, then they get 6 months to consider, but may have questions, or simply state that they're taking more time. I believe the greatest likelihood of a partnership will come after TLD is revealed, and may very well come before the BLA submission, so the partner will at least share in its development.

My point is that much may happen between TLD and approval. The data will almost certainly be presented at one or more major technical conferences for peer review, then it can be distributed to investors. Of course under confidentiality agreements potential partners, or buyers can have access to the data as soon as it's unblinded, even before the TLD statement is prepared.

We have roughly a month and a half to TLD if it's on time. We have a year or more before regulatory actions should be anticipated. An awful lot can happen between now, and then.

Gary
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