<a href="https://www.fiercebiotech.com/biotech/fda-extends-berens-rare-disease-review-after-info-request-further-stretching-saga" hreflang="en">FDA extends Beren’s rare disease review after info request, further stretching saga </a>
The FDA has delayed its decision on Beren Therapeutics' drug candidate for Niemann-Pick disease type C, extending the review period to November 17 due to the need for additional information and clarifications from Beren. This marks another chapter in a lengthy development process that began with the drug's discovery in 2009.
The key insight for you is that the FDA's delay in approving Beren Therapeutics' drug for Niemann-Pick disease type C highlights the regulatory challenges when relying on external control arms for clinical evidence. This situation underscores the importance of robust trial designs and the potential pitfalls of using external controls, which have recently led to setbacks for other companies in the biotech industry. For those involved in AI drug discovery or clinical trial planning, this emphasizes the need to anticipate and address regulatory scrutiny in trial methodologies.