Quote:We hope the agency will stop torpedoing promising drugs, but the story of biotech firm Sydnexis’s battle with the bureaucracy suggests more obstacles ahead.
I took a look at the FDA's Complete Response Letter and looked at the data from Sydnexis's trial. The FDA's complaint us that Sydnexis's drug becomes increasingly less effective over time. In the entire cohort the difference between year one and year three the effect is cut in half. The FDA proposes that by year four or five there would be little to no statistical difference between the drug and the placebo. That's almost certainly true. As the drug becomes less and less effective over time the level of myopia would be the same, drug or no drug. The ophthalmologists are up in arms over the CRL. Is that because they don't understand the science or that they hate losing income?
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