Dude, stop trying to mislead again, you are the one who led with your chin mocking Kelly for suggesting the possibility that a phase II trial might even suffice - he said it a possibility, and repeated "just possible" and you shot your mouth off as usual:
"Show us some examples where the FDA has given approval for commercialisation after a Phase 2 trial?" Pledge 14/12/23So I did show you Pledge that even back as far as 2012-2015 this was happening on occassion:
"For instance, AstraZeneca’s orphan drug Lumoxiti (moxetumomab pasudotox-tdfk) was approved in September 2018 based on one trial of less than 100 patients with a rare, slow-growing blood cancer. Stemline Therapeutics also won approval in December 2018 for Elzonris (tagraxofusp-erzx) to treat a rare, rapidly progressing cancer of the bone marrow and blood after conducting one trial of 94 patients in the US.Other cancer drugs, meanwhile, won approval after larger single trials.Pfizer’s Vizimpro (dacomitinib), for example, was approved in September 2018 on the basis of one clinical trial of 452 patients with advanced non-small cell lung cancer in Asia. Array Biopharma’s Braftovi (encorafenib) was approved, in combination with Mektovi (binimetinib) in June 2018 on evidence from one clinical trial of 383 patients with BRAF V600 mutation-positive melanoma that was advanced or could not be removed by surgery. The trial was conducted at 162 sites in Europe, North America and elsewhere.And Advanced Accelerator Applications’ Lutathera (lutetium 177 dotate) was approved based on one trial of 229 patients with a specific type of rare tumor at 41 sites in Belgium, France, Germany, Italy, Portugal, Spain, UK and the US.But not all the new drugs approved in 2018 based on one clinical trial were cancer treatments. For instance, Achaogen’s Zemdri (plazomicin) was approved in June 2018 as a complicated urinary tract infection treatment based on one trial of 604 patients in Europe, the US and Mexico.Paratek Pharmaceuticals also won approval for its antibacterial medicine Nuzyra (omadacycline) in October 2018 on the basis of a single trial of 774 patients with community acquired bacterial pneumonia at 86 sites in Asia, Europe, Israel, Latin America, South Africa and the US."
Lots and lots of examples in there. You predictably picked the first showing it had been withdrawn from market all pleased with yourself, demonstrating excellently that exactly opposite to yet another incorrect statement of yours,
it was in fact an excellent example of where the FDA had in fact given approval for commercialisation after a Phase 2 trial. Refuting your own statement....again.You are hilarious. You accuse me of leading with my chin. Metaphorically, I have never seen a better example of a boxer feign the opening his guard for the stupid opponent (that would be you) to throw a oh so predictable straight right and lead yourself wide open for a slip upper-cut. The unusual thing is you managed to somehow punch yourself in the face
(20min delay)
