That is one ridiculous statement. Was she supposed to wait for the framework to be in place before submitting? Then she should have submitted the MAA next month according to your logic. So we're another year or more waiting? This is a paradigm shift treatment. Take a deep breath and stop bellyaching.
Once the SAP was approved for both the PIP and Phase 3 trial the down payment was made on approval and a change in guidelines created to cover the call. This is a classic cart before horse situation but the cart is clearly ahead of all others. Just waiting for a government agency to catch up and get in front of what is currently ahead of them; ). This situation sure would have made for a great Norman Rockwell Saturday Night Post cover if happening in the US; ). Best wishes.
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