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Re: None

Tuesday, 11/13/2018 5:04:40 PM

Tuesday, November 13, 2018 5:04:40 PM

Post# of 688896
38-15-9

One theory.

September 16, 2015 End of German trial enrollments? (Probably) (LP spoke in London.)

- 15 months

= June 10, 2014 Start of German trial.

- 9 months

= Authorization for German trial September 17, 2013 and TFF patent granted Sept 10, 2013

In other words, under this theory, AVII is wrong, and they made a manufacturing incorporation during Phase III (not before conversion to Phase III). UK also started their trial initiation around here. Does anyone know the exact date in 2013 the UK started enrolling -- Fraunhofer/Cognate made UK's DCVax-L.

The recent find by Lykiri would seem to suggest TFF would be considered similar to pre-TFF.

It is stressed that not all changes to the manufacturing process can qualify as a change in manufacturing technology. For example, a change in manufacturing process (e.g. cultivation of cells in an open system vs. a closed system; change in the number of cell passages) or a change in equipment (e.g. upgraded bioreactor) generally cannot support a finding of non-similarity. -- European commission



Back to Blade Runner. -- Maybe we are not stupid. Maybe we adapted.

Just one theory.

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