I think this could be helpful to patients (including hair loss patients) if patients organized and petitioned the FDA for quick release of a medicine. Of course, I understand that the FDA still has to have some data before approving a treatment but the Cures Act allows some treatments to come to market with less evidence, possibly even skipping phase 3 studies in some cases.
http://www.npr.org/sections/health-...sed-to-pass-sweeping-law-covering-fda-and-nih
So it seems to me that if hair loss sufferers did some kind of petition campaign and submitted that petition to the FDA then there's a possibility that a breakthrough treatment for hair loss could skip phase 3 until after the treatment is marketed. This is especially relevant in connection with the Kerastem treatment which has already started phase 2.
Here is the language in the above story that interested me:
(1) "This bill, if it were to become law, would even give more prominence to the role of the patient in this process," he says.
(2) McClellan is also happy to see that the legislation gives the FDA more latitude to consider the needs and views of patients when weighing judgments.
http://www.npr.org/sections/health-...sed-to-pass-sweeping-law-covering-fda-and-nih
So it seems to me that if hair loss sufferers did some kind of petition campaign and submitted that petition to the FDA then there's a possibility that a breakthrough treatment for hair loss could skip phase 3 until after the treatment is marketed. This is especially relevant in connection with the Kerastem treatment which has already started phase 2.
Here is the language in the above story that interested me:
(1) "This bill, if it were to become law, would even give more prominence to the role of the patient in this process," he says.
(2) McClellan is also happy to see that the legislation gives the FDA more latitude to consider the needs and views of patients when weighing judgments.
