I do understand where you're coming from with that take on the PR...however...what would they have been submitting to the FDA for review on May 9th if it wasn't the clarification?

The FDA already approved the clinical protocol and the product manufacturing information that they provided on March 6.

I think they spent roughly a month gathering info for the clarification and submitted it on May 9th...my reasoning is they submitted all this originally on March 6...they had to hear back within 30 days...the FDA then told them the protocol and manufacturing was approved but they still needed clarification....so they gathered whatever they needed for the clarification and submitted it on May 9th