"The official said that the company could toss the data for the 65 and up participants and, perhaps, grovel. "It is entirely feasible that if they come back, maybe even show some humility and say, 'Yes, we didn't follow your recommendation. Just take a look at the 50 to 65 group, where there's a little more equipoise,' the official told Stat. "Then the review team could say, 'We'll consider that cohort.'""
"Prasad, who, according to the Journal's sources, told FDA staff that he wants to send more such refusal letters that appear to blindside drug developers. The review staff apparently pushed back, noting that such moves break with the agency's practices and could open it up to being sued. Prasad reportedly dismissed concern over possible litigation."
"The Journal notes that Moderna is at least the ninth company to have received a surprise rejection from Prasad and his team. The unpredictability is raising fears about the industry's ability to obtain investments and innovate."
Moderna largely kept a standard-dose plan but added a high-dose comparison for older participants and submitted extra analysis. Prasad reportedly wants to issue more refusal letters that surprise drug developers; review staff warned those moves could break agency practices and invite litigation. Trump’s FDA Commissioner Marty Makary suggested Moderna's trial may be "unethical." A senior FDA official said Moderna could discard the 65+ data and revisit the 50–65 cohort to gain reconsideration. Moderna is reportedly the ninth company to face such a surprise rejection. Prasad faces internal complaints and criticism over his management and misconduct.
Read at Ars Technica
Unable to calculate read time
Collection
[
|
...
]