I've never suggested CYP be a contract manufacturer. Whilst...

I've never suggested CYP be a contract manufacturer.

Whilst contract manufacturing is a specialty - the full scale up or scale out. (Aside: the recent article about Fujifilm 20,000 litre bioreactors - 8 of from memory with the option to add more - did not say what the bioreactors were to be for. No-one has grown MSCs in 20,000 litre bioreactors before). The prototyping of scaled down versions of larger scaled systems (where the essential components are maintained but the prototype being smaller is cheaper to build and uses less media) is something that can be done by say university research groups or smaller research/engineering teams.

I don't think CYP management has been consistent about its business strategy over time. The recent branching into a broader range of clinical trials seems to be a departure not a continuation of their early strategy which was to demonstrate with just one indication - GvHD - the principle and then licence.

I don't have confidence that CYP is going to be good at organising clinical trials because I don't think they organised the MEND trial at all well - they seem to have not anticipated that patients might not be available in Australia before incurring expenses and hiring staff.

Had Fujifilm made more progress in their own manufacturing of GvHD for phase 2 then they'd have provided by now further proof in principle of scalability. But they have not done that.

As far as I am aware the only inventory (cells for trials or pre clinical trials) CYP has is what they have obtained from Waisman Biotech when Waisman Biotech is not exclusive or full time for CYP and when the process described in the Nature Medicine (at the described in scale) article would only produce 77 doses per batch taking 37 days to do a batch. (They could serialise that - ie do the same thing in multiple instances - but they'd need the room to do that - or they could do it elsewhere that Waisman - but I don't think they have - the described process is not a closed manufacturing arrangement so it needs GMP facilities - a closed arrangement might not).

Bottom line there are lots of manufacturing process improvements even at the prototype scale that CYP could have done on its process (way below full commercial scale - but providing proofs they have that) that they have not reported doing. And in the reasons for cash raise they included optimising manufacturing. And in the Pitt Street report by Stuart Roberts - full scale commerical manufacturing was still flagged as a risk. And in the same report Roberts assumed all options held by directors would be taken up - which has never happened.