Replies to post #14576 on Algernon Pharmaceuticals Inc (AGNPF)

[Money $hot]

Here's a cheat sheet link:

www.biospace.com/article/fda-issues-final-master-protocols-guidance-for-covid-19-drugs-and-vaccines/

Master protocol trials are quite complex, necessitating “a high degree of up-front planning and coordination,” compared to standalone trials, the FDA pointed out.

“The FDA expects master protocols to continue to play an important role in addressing the public health needs created by the pandemic and in generating clinical evidence in general," Woodcock said.

55

It seems the Ifenprodil CT covered most of this guidance already.

Agreed.


@ AP

As part of the EOP2 meeting request, the Company is preparing a briefing package that includes a summary of Study data and a protocol synopsis for a potential Phase 3 trial. The EOP2 meeting is an essential part of the process to help guide the Company and determine the next steps forward.

The EOP2 meeting will focus on the data from three key endpoints from the Study including all-cause mortality, oxygenation (SpO2) and time in ICU, from the 20mg Ifenprodil treatment arm.

The question remains as to whether or not a BIG PLAYER will scoop up Nano Cap(sule) AP NP-120 @ Phase II or III or not?



Meanwhile... Ticktock Tick

M$