It is a very interesting article. Thank you for sharing, Simons77. I think what this may open up is more visibility of patient advocacy groups and a larger 'why not?' for the FDA to answer when assessing promising rare disease drugs and therapies.
At the pointy end appear to be gene therapies, which, while promising, still have many unknowns and serious risks. However, when I think about our company, it has consistently shown a good safety profile in its trials for both NNZ2566 and NNZ2591.
in my mind, if ever the FDA were to go out on a limb and seriously consider early approval of a 'first promise' drug (which we can generally demonstrate within 13 weeks), surely NNZ2591 would be a strong, lower risk candidate.
My opinion only and not investment advice.
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