Knight Therapeutics Inc T.GUD

Eli Lilly drug was rejected

[GoldenInvestor]

FDA Rejects Accelerated Approval for Lilly’s Alzheimer’s Drug

Published on:  January 23, 2023

Pharmaceutical Technology Editors

 

 

In a response letter, FDA stated that it could not grant Eli Lilly and Company accelerated approval due to concerns surrounding insufficient quantity of clinical trial data.

 

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Eli Lilly and Company (Lilly) announced that FDA had rejected its accelerated approval application for donanemab as a treatment for early symptomatic Alzheimer's disease on Jan. 19, 2022. In its response letter, FDA cited concerns surrounding an insufficient quantity of clinical trial data.

According to a company press release, FDA specifically requested that Lilly provide data from at least 100 patients who received a minimum of 12 months of continued treatment on donanemab. Lilly cited the experimental design of the study, which allowed patients to complete their treatment once targeted deposits of amyloid plaque were reduced to predefined endpoints, as causing the insufficient quantity of data. Lilly is currently in the middle of a confirmatory Phase III clinical trial (TRAILBLAZER-ALZ 2), with topline data expected in the second quarter of 2023.

"We anticipate [TRAILBLAZER-ALZ 2] will confirm the benefit and safety profile we observed in the TRAILBLAZER-ALZ Phase II study and believe that patients and physicians will be well served by having the full Phase III data available alongside our Phase II data when they need to make treatment decisions," said Anne White, executive vice-president and president, Lilly Neuroscience, Eli Lilly and Company, in the press release. "We are committed to working with the FDA to ensure the fastest possible path to bring this potential medicine to patients in need."

 

 

 

 

 

[gossamer18]

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[Chianchin]

Real relevant to GUD...Ha..? Anything to coufuse and desperately losing fortune  Aliasgold

[MrMugsy]

And regardless of any future success - not likely to make any impact on our sales. Just not competing in the expensive infusion space. IMO

[Chianchin]

Sales...what sales? I aks you again? What is GUD profits for the Alzheimer drug gud bought for over 200 million? 

[Chianchin]

As you all can see mad losing fortunes mugsy will never answears the hard inconvinent questions though he know best. Yep he knows how to lose forture thogh I think he/she/it buys one share at the time to average down, By now 100 shares 

[Spirou25]

all the info is on sedar. Go read a little bit. Profit has been gud on this drug.