Here are a couple more breakdowns, large molecule has a higher rate, 96% bla submission to approval. Also non-oncology has a higher rate still. The trial design was the fda standard, the safety data was best in class, efficacy higher than others approved with 350mg dose. The drug adds a benefit with weekly doses and no resistance found within R5. Also, Samsung greatly helps, read at the bottom link some horror stories I read Monday. I’m not sure which was the worst one, maybe hiding evidence that their insulin injections contained black metal particles or taking the FDA inspector hostage.



https://www.parexel.com/application/files_pre...rticle.pdf





https://www.wired.com/story/8-ways-overseas-d...-dupe-fda/