Cell Therapy News/Articles, page-1647

Bridging studies at the very least - potentially any manufacturing change (eg replacing FBS or going to 3-D) could raise both safety and efficacy issues, so FDA may require larger scale trials.

This is particularly so in the absence of any definitive marker(s) for potency.

If it were me, I'd push ahead with the cells they've been using in the trials and start getting some revenues in before contemplating a potentially expensive change - remember (particularly for the MSB cells, maybe not so much for the Osiris cells) the manufacturing process is efficient and scalable as it is, and produces consistent, potent cells). Pricing will initially be high, so COGS not so important at first.

Get people used to cells as first line therapy, the bring in the Mark 2 new improved cells (might even command a price premium!).