1. Under the current burn rate there is enough cash to last the remainder of the financial year (a bit longer actually). RAC will need more cash to advance all the trials we are planning, but not in the immediate future.
2. Yes this is the only trial currently running using Bisantrene, but it is not that relevant to RAC’s current research focus. I would encourage you to watch the AGM meeting video as it explains the new direction of the company in some detail and will help you understand the potential.
3. The IP is very secure - we have multiple patents with lifespans past 2035 and we also have orphan drug designation in the USA which grants the company 7 years exclusivity post approval. This prevents any company selling Bisantrene for 7 years after FDA approval.
4. In order to get the PRV we just need to do a small trial in AML in children. If Bisantrene were to perform as well as it has in past paediatric AML trials then Bisantrene would be approved by the FDA and we would be granted the PRV.
5. The cost of the paediatric trial is relatively low as we only need to include a relatively small number of children in the trial (30 - 40). The total cost can’t be calculated until the trial is fully designed and approved by the FDA (the cost will depend on what data the FDA will want us to gather and how long they will want the trial to run), but you could assume something well under $5 million at this stage.
6. Yes the PRV can be sold and used for any drug, even the next Viagra. Yes they are like magic tokens and the reason the FDA gives them out is to encourage companies to develop treatments for sick children with rare diseases. There is no way you could make money developing a new treatment for paediatric AML (it is too rare), but the PRV makes it worthwhile.
7. m2 is meters squared. For complicated reasons the dose of most drugs scales with the surface area of the patient, not volume or weight. This is why the dose of a drug like Bisantrene that needs to be closely matched to patient is adjusted on the basis of the surface area of a patient.
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