The more I think about it the more I start to wonder in which cases a drug has to show it's ability to ‘cure’ a disease compared to a drug that can be proven to reverse an adverse physiological event, which then in turn assists in the management of a condition.
For example paracetamol is an anti-pyretic medication that assists in reducing fever. It can be prescribed for a myriad of conditions, but primarily assists by decreasing temperature.
Another example is an anti-emetic drug like maxalon that can be prescribed for nausea, not for a condition, but to reverse or limit an adverse physiological reaction.
Take a look at CGT's second part in the first answer –
most people seem to believe that eventual treatment for TBI will involve multiple drugs.
If a physiological end point can be achieved in this drug that they know has benefit, but proves to be too difficult to prove functionally purely due to inadequate functional testing procedures, then this drug may well be used in conjunction with other drugs to help treat the physiological effect of the condition.
The question is does the FDA need to see a condition ‘cured’ or can the prevention of an adverse physiological reaction be sufficient for approval for use, like paracetamol.
This makes sense when considering the company’s statement about seizure endpoints being enough for approval. (sorry to go there again, but trying to out the puzzle pieces together)
Maybe NNZ-2566 can be approved as a tri-acting anti-inflammatory, anti-apoptosis and anti-convulsive/non convulsive seizure medication, for use in TBI and other neurological conditions requiring control of these three reactions, that will be used in conjunction with other medications.
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