So right TMW.
90 days is a guideline, nothing more.
Companies making submissions expect questions when FDA is looking for verification of data submitted.
For example the back is nite and day different from the foot and knee. The bones of the foot and knee are very close to the source of the SWT....the ActiPatch. Not so with the muscles of the back and spine where many sources of chronic and acute pain are farther away because of differing BMI and deep within large muscles and tissue (fat).
Whenever differing data shows up, questions are asked and answers given. It's not complicated, but the data itself can be complex to compile and present, just needs to be explained properly so new questions don't arise. One tiny question can add a month or two, it's the way it is. My guess is a question was received after the latest Whelan online interview. That may take us to December.
ActiPatch...imminent Tsunami...breakthrough disruptive technology...