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Lrich

09/14/20 2:24 PM

#298903 RE: HDGabor #298853

If so JT is a liar.

JT came out and claimed they were going slower than average, and revised the timeline to be early 2021 instead of 2020, but blamed it on COVID. If you are claiming this is average, you are unequivocally stating that JT is a liar. He misrepresented the initial timeline.

That said, I disagree on this being average, we're talking the maximum time allotted per the EMA. Yes, there was a clock stoppage issue due how the months align. Not acceptable, this should have been planned for earlier (and JT should have known this when giving the timeline).

As well, there should have been no delay their submission to the EMA, unless they are going to respond at a well above average speed.

There should be no list of outstanding issues. Management botched this too. In the simplest terms, they should have submitted in March 2019. When they failed to do this, they should have submitted in August 2019 (at the time of adcom, they would have still not gotten their questions back prior to adcom). When they failed to do this, and filed in December, they should not be taking the maximum allotted time to respond. Especially after the loss in March.

There is no excuse for all of the delays. Any one would be acceptable. The collection is not. Fire John Thero