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Re: hoffmann6383 post# 481180

Thursday, 06/02/2022 4:43:55 PM

Thursday, June 02, 2022 4:43:55 PM

Post# of 687147
Hoffmann,

It has been some time, but I believe the company had guidance from either the FDA or NIH that indicated that a quiet period should exist after a trial data locks until the company releases a TLD statement. The company has worked in accordance with that guidance, but it was their choice to hold the TLD statement for the Journal.

It's my belief that they could have issued a TLD statement within 4 to 6 months of the data lock, but such a statement being only a few paragraphs would have left many questions unanswered. They believe that it would leave them open to short attacks that couldn't be answered until the peer reviewed Journal was out. They made the choice to not issue the TLD statement until peer reviewed information was available.

I would hope that if the Journal isn't out by Saturday they choose to issue the TLD statement on the strength of the NYAS presentation. I would suspect that if Dr. Bosch does make the presentation, a TLD statement will accompany it as he is an official of the company and making the presentation. If the entire conference were turned over to Dr. Ashkan, then it wouldn't be the company speaking, rather a clinician in the trial, and he wouldn't be expected to make a TLD statement. I still believe that Dr. Bosch will lead the conference, Dr. Ashkan and others will play a part, and perhaps some of the longest survivors will as well, and even LP may be called on for some guidance from the company. I just doubt that Dr. Bosch will do a full hour by himself. Nothing has been said about Dr. Liau making an appearance, if she's at ASCO I wouldn't be surprised if she did.

I see my Dr. at City of Hope next week, I doubt if he's going to ASCO, I don't believe he's making an appearance there, though he has in the past. I know GBM isn't his area of expertise, but I previously mentioned NWBO to him. If he's there, I hope he at least had a look at the exhibit. I do know that COH did participate in the trial, but that would have been a different department there.

The company is clearly waiting for practically the last minute to officially announce what's happening Saturday. I feel certain they'll announce it, but I have no idea whether they'll provide information on what's being presented and who the presenters will be, or not. Hopefully we'll see it by tomorrow at the latest.

Gary
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