Here are Ross MacDonalds answers to your exact questions which I emailed to him. He responded and said I can post no problems.
1. why don't we sell our manufactured stem cells to companies that provide stem cell treatment?
THE USE OF ALLOGENIC STEM CELLS AS MEDICAL TREATMENT REQUIRES APPROVAL FROM RELEVANT NATIONAL REGULATORY BODIES, JUST LIKE OTHER THERAPEUTIC PRODUCTS. THIS IS THE PROCESS WE ARE NOW COMMENCING AND THE INITIAL USE WILL BE IN A TRIAL IN GVHD. ONCE THE PRODUCT IS PROVEN TO BE SAFE AND EFFECTIVE, WHICH TYPICALLY REQUIRES SATIFACTORY COMPLETION OF A PHASE 3 TRIAL, THE AUTHORITIES GRANT APPROVAL FOR SALE. SO, WHILST WE COULD SUPPLY OUR CELLS TO OTHER COMPANIES, THEY WOULD NEED TO UNDERTAKE THE SAME APPROVAL PROCESS BEFORE THE CELLS COULD BE USED IN TRIALS AND POTENTIALLY EVENTUALLY BE SOLD AS AN APPROVED THERAPEUTIC PRODUCT. THIS IS FACT WHAT WE ARE DOING WITH OUR EXISTING PARTNER, APCETH.
2. Why are those companies not interested in buying the product and using for treatment?
I THINK THIS IS COVERED ABOVE. APCETH ALREADY IS INTERESTED AND WE HAVE ONGOING DISCUSSIONS WITH OTHER PARTIES TO THIS END.
3. Are we going to do 3 phases of clinical studies now for every possible illness that stem cells can be used for?
EVENTUALLY THIS WILL BE REQUIRED, BUT IT IS OUR PLAN TO HAVE OUR PARTNERS (EG APCETH) UNDERTAKE SUCH TRIALS AT THEIR COST. NOTE THAT IN JAPAN A THERAPEUTIC STEM CELL PRODUCT CAN POTENTIALLY BE COMMERCIALISED AT THE END OF PHASE 2.
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