TJ Skins
CPn10 is a biologic and has previously been produced in e-coli. This is a batch process of fermenting in vats and purifying. To produce sufficient for trials would require a dedicated section of a commercial facility. Everything has to be produced under strict supervision in accordance with FDA protocols. This is a very expensive process and is only economical if a substantial quantity is produced. As a rough guess, I would say that from time of decision to proceed, it would take three months to develop a programme and raise the necessary cash, three months to find an appropriate manufacturer and negotiate a deal and then six months to produce a batch. facilities capable of doing this are not sitting idle waiting for the call from IVX. Bear in mind that if we accept the $5M figure to produce the drug, we would also need a similar amount to conduct a meaningful trial. This is why I support the strategy of finding a partner for CPn10. The above time frames may be a bit compressed with the support of a major which may have their own facilities or already have commercial arrangements which help. I am not an expert in this and am quoting figures from the previous management, which may be inaccurate and are a little out of date.
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TJ SkinsCPn10 is a biologic and has previously been produced in...
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