The FDA advises that, to maximise the benefits of BTD, drug sponsors should submit their BTD request by the end of the EOP2 meeting with the FDA and before the initiation of the pivotal trial.
Following submission of the request, the FDA has 2 months to give its response.
A request for BTD can be made more than once (it was made twice for trofinetide) and is not a public process. Therefore, it’s possible that Neuren has already requested BTD for NNZ-2591 in PMS and been knocked back.
From a regulatory help perspective, Neuren probably stands to gain little now from gaining BTD. But from a public relations perspective, the market can perceive BTD designation to be like the awarding of a gold star for a drug; hence, it can positively impact the share price of a publicly-listed company.
Those who have been keen to see Neuren receive BTD for NNZ-2591 may take comfort from the fact that Soleno Therapeutics, which last month received FDA approval for its drug for Prader-Willi syndrome, was granted BTD last April. The successful request was based on interim Phase 3 results , which were announced seven months earlier.
This proves that the BTD possibility remains alive for Neuren.
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