Innovation Pharmaceuticals Inc (IPIX)

[wsbc]

except...

A large group of outside experts at the FDA has slapped down Alkermes’ campaign to gain an approval for their depression drug ALKS-5461, objecting to a messy set of data and the way the biotech managed the study and reported the data.

from here: https://endpts.com/fda-experts-gun-down-alkermes-pitch-for-alks-5461-slamming-the-company-on-multiple-fronts/?utm_medium=email&utm_campaign=600%20Nov%2011218%20JJ%20axes%20CD28%20autoimmune%20partnership%20Experts%20question%20Amarins%20early%20touting%20of%20Vascepa%20data&utm_content=600%20Nov%2011218%20JJ%20axes%20CD28%20autoimmune%20partnership%20Experts%20question%20Amarins%20early%20touting%20of%20Vascepa%20data+CID_37f57d46eba0400c2b26b05c61e74ea8&utm_source=ENDPOINTS%20emails&utm_term=FDA%20experts%20gun%20down%20Alkermes%20pitch%20for%20ALKS-5461%20slamming%20the%20company%20on%20multiple%20fronts

"FDA doesn't agree to EOP meetings without merit."

"Requests for Type B and Type B (EOP) meetings will be honored except in unusual circumstances."
https://www.fda.gov/downloads/Drugs/.../Guidances/UCM590547.pdf
p.7