That's the way that company sees it. The SEC guide

That's the way that company sees it. The SEC guidelines are broad enough to leave it open to interpretation by each company. By being so broad one may not know whether the SEC thinks you're in violation until they contact you. Our COB will probably operate with an abundance of caution both ways and most likely file with the SEC about a BLA submission. She most likely would not for any preliminary trial results but would for topline results.