Ann: FDA commences substantive review of EBR PMA application, page-21

From EBR's September In Review, emailed to interested investors:

"Premarket approval application formally accepted
"There’s more good news following the successful capital raise. The U.S. Food and Drug Administration (FDA) has formally accepted EBR’s final premarket approval (PMA) application for the WiSE CRT System.Submitted at the end of August, the PMA application was subject to a 45-day review period to ensure the application met the standards for substantiative review."

"The FDA took just 30 days from submission to provide confirmation of its acceptance - an encouraging sign ahead of the substantive review. We now enter the substantive review phase, which typically takes 180 days."

The question in my mind now is :-
Will the quick turnaround by the FDA in confirmation of the substantive review translate into an also quick review of the WISE PMA?

The Breakthrough Device Designation ensures a prioritised review process according to the Company, and therefore its possible (likely?) that the FDA substantive review may be progressed quicker than the usual 180 day typical turnaround.

IMO EBR's share price is only being discounted now because of the anticipated 180 day review period. If that review period is reduced similarly to the FDA confirmation of acceptance then we are on a much tighter schedule for any likely re-rating of the share price.

And of course I take comfort that the CEO is of the opinion that this is not a binary decision any more. It has already met its safety and efficacy targets within the SOLVE-CRT trial completed more than 12 months ago.
PLUS
EBR is well funded to commence the commercialisation of WISE through its already established clinical network (through the SOLVE-CRT trial).

And as the Company states:
"The CRT market is highly concentrated -targeting high-volume CRT procedure sites."

Some exciting times ahead for EBR security holders.