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I don't remember which of the calls it was on, but

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Post# of 154912
(Total Views: 560)
Posted On: 05/14/2020 3:46:02 PM
Posted By: Respert24
Re: nmbr1stckpckr #34032
I don't remember which of the calls it was on, but JL dropped dates saying they'd submitted their data on something like 4 different dates so far and it hasn't been granted. But you're right, they didn't go in depth about any of it except with the usual generalities sprinkled throughout the calls where they keep referencing how the FDA wants data before they do anything. Perhaps they were pushing for flat out approval versus compassionate use approval in some or all of those earlier attempts. I'm hoping this time it works as we have the data for a significant amount of patients. We have the sickest of sick at Montefiore, we have the rantes information which they said they've shared with the FDA, and a whole lot of other EIND patients so far. As a result of everything that's known at this point (all the EIND patients) and with this new discussion from yesterday about putting together protocols, I'm leaning toward this being the time we get compassionate use approval.


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