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skitahoe

01/15/22 10:36 PM

#435489 RE: flipper44 #435488

Flipper,

I would have to think that the finish line the company would be talking about would be the BLA. The Journal should be Dr. Liau's baby, FlaskWork's belongs to the FlaskWork people. I would hope the update to Clinical Trials is done, just needs to be sent. That leaves the BLA which is really the most important thing the company is working on.

If the BLA is near submission we should understand just how close we may be to the first approval. Everything that seems to be happening in the U.K. makes it sound like it won't take long there, perhaps no more than a month or two.

Of course it's possible that the regulators have agreed to work together on this, and will all approve at once. I believe it would be unusual, but then again, this have been a very unusual trial.

Gary
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hoffmann6383

01/15/22 11:04 PM

#435490 RE: flipper44 #435488

yeah

saw that post. that was a vague post imo
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meirluc

01/16/22 12:57 AM

#435492 RE: flipper44 #435488

Dr. Bosch and any staff member assisting him to prepare his talk only required a maximum of six working days before the day of the presentation. You would think that at more than 15 months past data lock, NWBO would agree to postpone the TLD/publication preparation for a few more days and let Dr. Bosch present, unless the time spent on the presentation would have risked a delay in release of the publication.

If DR. Bosch's final preparation for his talk could have caused a postponement of TLD/publication, the decision to cancel the presentation was correct (IMHO).
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HappyLibrarian

01/16/22 10:18 AM

#435516 RE: flipper44 #435488

I guess the doctor was going to use the undergraduate approach of doing the work the night before because otherwise shouldn’t most of that prep work been done?