banter and General Discussion, page-9365

It’s interesting as you say, @Phaedrus, no matter which way you look at it, but gets even more so if there are real prospects of looking at adjacent indications if and when Ryoncil is approved for SR-aGVHD. Dr. Lightner as the PI was and from what you say, still seems to be the custodian of the important data the company would need to take to the FDA if a relevant discussion is to be had. From memory, the P2 trial data were very good despite its small size and safety being the main focus of the investigation.

I would argue Dr. Lightner’s keen interest, if not passion, in research, in particular the stem cell variety, even before she became a fully fledged specialist/surgeon, also stands Dr. Lightner in very good stead if the company were to consider boosting its bench strength to support any Ryoncil for GVHD launch, allowing it to showcase that ahead of landing a pharma partner either for Ryoncil as a whole or for the IBD indication on a standalone basis maybe a bit further down the track. Having an expert clinician like Dr. Rose talking to the FDA about stem cell for LVAD patients, I am guessing, probably made the regulator sit up and listen more to the company. It could perhaps do the same with a hearing with an IBD expert at some opportune time (such as approval time for Ryoncil for aGVHD), or as soon as the company can pull together a coherent message with the trial data to highlight the similar symptom presentations of IBD or some form of it, and GI GVHD. After all, 70% of our immune cells resides in our GI gut.