Replies to post #3082 on Spectrum Pharmaceutecals Inc (SPPI)

[1sdestiny]

Thanks for the history. Really appreciate your knowledge and helping me understand this process.

[cuggegrosse]

DR RAJ IS A CLUELES THIEF

[antihama]

having the confirmatory trial substantially enrolled at the time of approval I think is penance for past sins by Dr Raj.

Actually, starting a confirmatory trial prior to accelerated approval is the new way of thinking regarding AA at the FDA. From FierceBiotech.

The accelerated approval program has come under scrutiny recently, primarily following the approval of Biogen’s Aduhelm to treat Alzheimer’s disease. The top issue at play for the FDA is consistent but nevertheless contentious: how to balance a lack of options versus a lack of data. In the case of Aduhelm, the agency approved the drug against the recommendations of its advisors.

In a recent interview with Fierce Biotech, FDA Commissioner Robert Califf, M.D., suggested one way to improve faith in the program would be for companies to launch phase 4—also known as “confirmatory”—trials before a drug nabs approval. It was an idea he got from the agency’s oncology chief, Robert Pazdur, M.D., who noted in a separate interview with Fierce Biotech that the agency is hoping to expand the accelerated approval program in cancer.

https://www.fiercebiotech.com/biotech/u2-disbands-crushing-step-back-tg-therapeutics-retracts-approved-cancer-med-bla-combo