Theratechnologies Inc T.TH

More flexible FDA

[scarlet1967]

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.

[Wino115]

TH1902 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

[scarlet1967]

  It’s interesting to see the pricing for Oncopeptides’s PDC Pepaxto for multiple myeloma.    “Melflufen was administered with dexamethasone according to the following dosing schedule: melflufen 40 mg on day 1 and dexamethasone 40 mg on days 1, 8, 15, and 22. Patients received treatment until disease progression or unacceptable toxicity.”   It

[SPCEO1]

If it shows signs of efficacy, I have to think BTD is a near certainty. The way they have characterized their interaction with the FDA on Monday makes me wonder if the FDA is already acting like it has implied BTD as them seemed very involved in this trial.

[scarlet1967]

"Off topic but the Lily drug is vastly cheaper than the Biogen one"   One has to wonder if the price tag on the drug was not as expensive would it be same response from the politicians? Well they seems to be more focus on  straightening the budget deficit rather than patients care! It’s all about money walks the talk.   “Senate Finance Democrats took aim at Biogen