They tweaked the S-1 again. No time to review in any detail, but it looks like an administrative thing to me. I did notice that they added "CLIA" certification to their lab status (they've had that for a while, but it's new to the S-1). I don't want to overinterpret that, but it could be interesting. Their lab and manufacturing platform are distinguishing factors. If you remember, the FDA shot down a Mesoblast application a few years ago, despite near unanimous recommendation for approval from the advisory board, because of concerns with characterizing the actual product (as well as concerns about vague mechanism of efficacy, which I personally found to be BS). Mesoblast was also farming out its manufacturing, which didn't help (not sure what it's doing these days).
My sense is that VB is emphasizing its unique and proprietary manufacturing platform, which of course depends in large part on those certifications. If and when big pharma should ever lose its grip on the FDA, along with its ability to sabotage approval of cell-based treatments, the demand for a US-based lab with strict manufacturing and quality standards could mushroom almost overnight. This is such a feast or famine play. I knew that when I invested, but I didn't expect almost 20 years of this nonsense.
