Monday, July 24, 2017 12:52:31 PM
Ok so the company has been predicting trials for some time.
1. Everyone who knows anything about bios know they always take years longer than we think. Even the big pharma under predict the time trials will take.
But here's the thing....
2. We met the FDA and they agreed the submission should be for a pivotal trial
A pivotal trial.
Does everyone realize how amazing that is?
Does everyone understand that this time we are so so close and have never been so lined up ever.
That the FDA looked at the pre ind and said go straight to pivotal.
They agreed the cell we should use. It takes about 24 weeks to get them ready if no one else is in the queue.
They're expected third quarter. Validated and ready for the trial. We have to have those cell banks to submit.
We've never been closer.
Move on.
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