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staccani

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staccani

Re: lammy01 post# 495

Monday, 10/07/2019 12:02:26 PM

Monday, October 07, 2019 12:02:26 PM

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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)
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