There is no proof that the FDA ever asked ANY company for a "pre-submission meeting," let alone BIEL.
The FDA never requests a meeting with a company. I mean NEVER. The company requests a meeting with the FDA, not the other way around.
The FDA also never asks a company for more data or evidence or materials. The FDA told BIEL they would not clear the ActiPatch for other indications without more clinical evidence. They did NOT ask BIEL for a back study or for anything else.
Therefore, BOTH of these statements are BS. Beware the BS.
“The FDA has requested a pre-submission meeting." “The FDA has requested a back study from BIEL."
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