All talks and execuses for delays. Yo don’t get clearance with the FDA because it is cool, but rather something that is going to translate to sale and deal making. This current CEO does not know who to do that. He needs to step aside as he is the MAIN PROBLEM for the company business success.
We got the foot clearance almost two years ago. It took the clearance another year and a half to happen. Now we are talking 3.5 years of preparation with nothing on the business side. Same thing on the knee side as well.
As for the 510K on ALLAY and post operative, they are nothing but delay tactic to mislead investors.
a. We need BIEL to focus on product sale
b. We need a new CEO who know how to run companies to lead company
Without the above, it is going to be business as usual. Dilution for nothing.