Yes, some kind of modification to the device was mentioned in the last conference call. I guess this must have been it. The CEO confirmed it did not impact current de novo application.
I think the management have been a little conservative here on the approval time frame. They may have included another round of FDA questions which may or may not eventuate. They have responded to the last round, so in theory we are waiting on their review and final rubber stamp.
Based on some recent SP responses to FDA approvals for a few device companies (LBT and AHZ) I think we are in for good 30-50% jump on approval news, imho. I took the opportunity to top up yesterday based on the dip and what I have been observing with LBT and AHZ.
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