@alec93@BiotechAutist Draft label is not special. Field trial data failed an its riding on a Chamber trial that is supposed to be “supportive” only if real world data shows efficacy
@surferbackpack This is a great write up! Thanks for the input.
One consideration, I would add:
The Feb 16 date for providing feedback prior to the PDUFA
If the agency identifies major deficiencies that affect the ability to file company would absolutely have to PR that on Monday or Tuesday
We’re pleased to share the U.S. FDA has granted Breakthrough Therapy Designation to our investigational treatment for metabolic dysfunction-associated steatohepatitis (MASH).
Learn more: https://t.co/w9QZSj2Dm9
@AldiUSA new downtown Brooklyn location looks like garbage every day since before the New Year. Trash never gets picked up off the floor and open packages litter the floors. The very few staff are rude and unwelcoming but make sure to let you know it’s 30 minutes before closing.
Today we hosted our virtual R&D Day where we shared updates and future development plans for #pemvidutide, our GLP-1/glucagon dual receptor agonist for #MASH as well as AUD and ALD.
Watch the full replay here: https://t.co/DV0ad0WgOW
@MattNachtrab What about the updates from patients in the trials that you were tracking? What possibly could have been the thing affecting the change other than sugar in a pill?