What on earth would make a biotech company change the primary endpoint half way through a Phase III program and not discuss it with the FDA? There are at least two scenarios, neither of them good.

The company plans to make a new EUA request prior to filing a BLA, but does not yet have a specific timeline. Meanwhile, it has been preparing for the drug’s distribution as a COVID-19 treatment.

While some cancer centers report sufficient stocks of the drug, they have already been turning to potential alternatives due to supply issues that could last for weeks or months.

Pfizer and BioNTech sent in Phase I data for a third dose of BNT162b2 to support future licensure, Gritstone bio will work with CEPI to develop its second-generation vaccine in South Africa and other areas, and Roche Genentech expects a shortage of the drug Actemra to last for several weeks amid a surge in cases.