RE:More flexible FDATH1902 appears to me to be teed up for Breakthrough Therapy Designation since it is first in class targeting sortilin and having that huge payload on the peptide. I would expect BTD on Phase 1 data if it performs like the lab. BTD would also be an attention grabber for the program and hopefully get it some coverage by analysts and new investors who monitor oncology.
Off topic but the Lily drug is vastly cheaper than the Biogen one. I don't know about efficacy but since Biogens barely beat sugar tablets, Lily will take that market. Thankfully as the estimated annual costs for Medicare (elderly insurance) were $6bil to $29bil a year all paid by govt plans.
scarlet1967 wrote: Biogen’s pricey recently somehow controversial approved Alzheimer’s drug sparked a bit of criticism from some folks within FDA as they didn’t believe the therapeutic benefits of the drug justified the approval, few resigned but the temporary commissioner Janet woodcock who many blame for the approval of the drug seems to have backing of senate members from both parties, there are also many patients advocacy groups including oncology groups who have supported her in the last few months. Even president Biden has defended her in her decision making efforts. Now Lilly is filing for accelerated approval for their Alzheimer’s drug. As many hardliners within FDA have left we could see more flexible FDA which is open to approvals of drugs for unmet conditions NASH and late stage cancers included.