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skitahoe

12/15/19 12:06 PM

#255801 RE: Lykiri #255780

Thanks Lykiri,

I'm glad it's incorporated, and while I suspect it makes evaluating the data somewhat more difficult, the net effect is certainly very positive, and would be even more so if the entire trial had been run with the improved version of L. In the past I've seen the FDA require more for all sorts of reasons, I just hope this isn't one of them.

If they hadn't used the improved vaccine, I suspect the FDA would insist on a new trial with it before approving it, though they may have approved the lesser version. Hopefully it's the data that wins out, not the confusion that may have been caused by both better vaccine and the initiation of improved surgical techniques.

It sounds like we've had greater support from certain regulators, and that could also be reflected in the time to approval. The FDA might be last, but hopefully won't insist on another trial, but if they did, it could be supported by sales in the other countries. Of course a BP partnership before any of this happens will ease the process, but it may not avoid all delays.

Gary
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Leprecon7777

12/15/19 3:10 PM

#255816 RE: Lykiri #255780

Lykiri,

Based on your due diligence, do you have a theory regarding the partial clinical hold?

Thanks in advance