I take encouragement from the fact that a lot of mileage has been done since the first, not well deserved, CRL, and especially in the last 18 months. This will give the company an almost unassailable and rigorous IP advantage and understanding of how to tackle regulatory access vis a vis competitors. When a first product is finally up and running and being sold, the industry will start looking very different with indications that depart radically from the way stem cells are currently maybe used in cosmetics and minor ailments, and even where they may be used in more serious illnesses, the level of assurance will be entirely different with the FDA stamp of approval. This navigating of a journey from where there is little regulation to where we are currently - still close to the start - is fraught (and don't forget the massive Covid-related interruptions), and people like Pledge, rightly or wrongly, have asked why we have taken such a difficult path and perhaps not looked at jurisdictions outside of the US. I don't have the answer, but there is no doubt that the patient benefit is going to be substantial when commercialisation is finished.
I look forward to some better news.
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