If safety and any degree of efficacy is shown in the treatment of the two forms of XP the company is currently investigating, why won't accelerated approval pathways be open? XP is currently untreatable and is fatal - exactly the kind of conditions most of us understand accelerated routes to market are designed for. Success here, if it occurs, could provide a solid base for entry into other applications in the longer term. No one expects this to be a single stage process. I'm not aware anyone has ever claimed it would be. The company is already profitable and cash generative on EPP alone. It is self funding, and looks likely to be through the development phases for other indications. One of the major risks facing biotech investors is constant dilution through multiple capital raisings, but maybe we've got that wrong too.
We all know drug approvals are conditional, and subject to constant, continuous review. You're not telling us anything unknown. As before, you appear to consider melanocortins useless because big pharma hasn't developed them, but because a whopping 4% of drugs have had approval revoked the whole industry is a house of cards. Could you kindly explain why big pharma is always right, but, at the same time, sometimes wrong?
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