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Thursday, April 29, 2010 5:12:42 PM
I understand as I am not happy here in PDMI either as I am still holding PDMI. Since the FDA website did not list any change of the committee held on 23 Apr 10 for the FDA approval for the devices, it means that the committee had commenced as scheduled per what the FDA tells you when you call them.
I think the FDA approval for PDMI looks like it either didn't make this cut of approvals from the previous FDA approval meeting or the submission is still being reviewed for approval. The PR today just wasn’t what many were hoping for. The PR today did confirm that they were not disapproved or not accepted. It stated that they were still waiting so all hope is not lost.
v/r
Sterling
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