Ann: Pivotal Trial Protocol - Update, page-14

People can spin this whatever way they want but it appears to be more of a formality than anything; "review points" and "outcome measurements" stand out here. I believe that they want to standardise the outcome measurements used or expand on why they used the review points that they did. It is not uncommon for researchers to be thorough with this sort of thing as it is essential for constructing appropriate outcome measures/end points which the clinical trial will be structured around. Once these things are confirmed and the trial research protocol is confirmed then patient recruitment will begin, there is a strict order to these things. Given BTM is a new product, "take rate" is not a standardised measure of effectiveness so the FDA would require more clarity on what this means and it's clinical relevance.

The feasibility study had two primary endpoints/outcome measures.
1. BTM ‘take’ rate assessed after integration and at the time of sealing membrane removal,
2. Split-thickness skin graft (SSG) ‘take’ rate at 7–10 days after application.

The second interesting point of note is that funding for the study is complete given they will announce it immediately once FDA approve the IDE.