The DFA Discussion, page-85

Mate I’m not a scientist - but here you go from ChatGPT - here are some actual examples of high-quality, double-blinded, multicentre RCTs that were unblinded early — often around or before full data collection — and still led to FDA approval:

1. Lenalidomide (Revlimid) – Multiple Myeloma
   CALGB and IFM Phase 3 trials were unblinded early after strong interim results. FDA approved it based on those results.

2. Natalizumab (Tysabri) – Multiple Sclerosis
   Unblinded due to safety concerns (PML). The trial was halted, reassessed, and reapproved with full FDA oversight.

3. Aducanumab (Aduhelm) – Alzheimer’s
   Trial was stopped for futility, then unblinded. Post-hoc analysis showed potential benefit. FDA still granted accelerated approval.

4. Alectinib (Alecensa) – Lung Cancer
   The J-ALEX trial was unblinded early after interim analysis showed a clear efficacy advantage. Drug was approved.

5. Tasimelteon (Hetlioz) – Sleep-Wake Disorder
   Adaptive protocol, unblinded early for therapeutic analysis. FDA approved it for use in totally blind individuals.

All of these were tightly regulated, and in some cases, even unplanned unblinding still led to approval. The key was how the data was handled — not just when it was unblinded.