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staccani

10/07/19 12:02 PM

#496 RE: lammy01 #495

http://www.irdirect.net/prviewer/release/id/4042654
The meeting with the FDA is to discuss whether the 6 months interim data (which was presented in July), is enough to grant AA in addition to the cardiac and respiratory data . I guess today's additional data was necessary to complete the PUL 2.0 data with shoulder and distal at 6 months (mid level data was reported earlier)