We really don't know at this stage beyond that the first engineering batch has been rock solid at room temperature for more than 12 months. Based on what we know about bisantrene and the various other components of RC220 I expect that it will be stable for longer than 10 years as long as it is keep in the dark and dry (which it is).
We can and will make more RC220 as we progress. Part of what the regulators want to see is that you can make consistent batches of your drug at ever larger scales - after all there is no point approving a drug if the company can't actually make it.
Ann: RC220 cGMP Manufacturing Complete, page-39
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