“It is not uncommon for a drug with Fast Track Designation to be...

“It is not uncommon for a drug with Fast Track Designation to be granted Breakthrough Therapy Designation during the drug development process”

Here’s hoping breakthrough designation is granted in the head and neck indication along with “stella” top line data in the upcoming data cut.Breakthrough designation typically takes around 60 days to be granted ,and we know from a recent announcement that head and neck data cut off was February.Allowing time for data collection and cleaning brings us to around present date or a little longer.Breakthrough designation allows the company to apply for priority review in 6 months.Priority review in the US and accelerated approval in the EU would make for an ever faster path to commercialisation.

Maybe wishful thinking but a licensing agreement , with lung cancer design and a commencement date, following the above would be handy.Potentially throw in an equity stake with the already in place shelf registration and the company would be sitting pretty
If Merck ,who would be the obvious suitor ,is unable to buy out the company or secure an exclusive licensing deal maybe second best is an equity stake in the company as part of a partnering agreement.
”EFTI is not just an enhancer of Keytruda “

”I have a good reason for not releasing the trial design within the stipulated time frame”


DYOR