The FDA's draft document Manufacturing Changes And Comparability...

The FDA's draft document Manufacturing Changes And Comparability For Human Cellular And Gene Therapy Products makes it clear that any cell or gene product in the future is going to be subject to at least the same level as scrutiny on manufacturing, potency assays, comparability studies etc etc as that which Meso is currently going through.Meso has the advantage of years of data in the largest P3 trials ever conducted in MSC/stem cell therapy products, huge amounts of statistical analysis and has already had the manufacturing plant approved.It appears FDA will put potential future competitors through at least the same level of riogorous scrutiny.Once Meso is approved, it is likely to have the field to itself for a long time.This broadens the moat and would make Meso very attractive to any big pharma wanting to get into the field as the Meso database and analytics could save years of work and hundreds of millions (over $1bn spent to-date) in trials and manufacturing experience. Big pharma need new avenues of growth as their products come off patent in the next few years - they don't have the time to waste on years of stem cell trials if this is to become a growth area.Maybe this is why Meso continue to talk about strategic partnering deals and the chairman mentioned taking the heart failure programme forward in partnership with global pharma in the Ann Rep. and SI talks about potential strategic partnerships in Back Pain to leverage existing commercial channels (Surgcenter)

Interesting

Aloha.