MSB All-time low Party Thread, page-296

We should not forget the US marketing regulations are very different as off label is also allowed. We know from SI's statements that our therapy will be priced in line with CART T cancer treatments, $500 thousand would be a fair estimate, we however are not looking at a very large population. Just 100 patients and we past break even. Both Canada and NZ have given conditional approval so I would think it highly likely that with FDA approval these countries would give access to their market in response. I would be very surprised if Europe did not follow. From memory Australia declined on similar grounds to what the CRL was issued on. The flow on effect from US approval will be significant.

The huge market will be in other indications like IBD and possibly ARDS.

Many here complain relentlessly about lack of progress since the CRL setback. In my opinion this could not be further from the truth. At the time of the ODAC meeting OTAC did not agree to our final potency assay ,CEBA agreed and issued the CRL. Now we know that OTAC have agreed to our new potency assay . This was a huge step forward, all that remains is for CEBA to review the data and agree that it is adequate.

Given that both Remestemcell-L and Rex. have similar CQA we can be reasonably sure that similar technologies will be used as a final potency assay for both products.

Good luck all.