3 ms·
nothing was skipped maybe aside from testing on animals first. it was however on a compressed observational and manufacturing timeline. normally a company doesn
by weaksauce 6y ago
nothing was skipped maybe aside from testing on animals first. it was however on a compressed observational and manufacturing timeline. normally a company doesn't want to run the next trial while the previous trial is ongoing. they compressed stages one and two(safety studies where they do tens of people and then hundreds of people to strictly look for adverse outcomes). Then they did a efficacy trial in stage three of thousands (which also looks out for large adverse outcomes). the regulatory review stage was also shortened because the drug manufacturers were supplying more real time data to the regulators to expedite the approval. the normal way they do it is to run every stage back to back and then after stage 3 is finished they would submit the data to the fda and get an approval back within a year or two. Then the manufacturing would start to ramp up... this was a moonshot type of project that hoped the trial would be successful and started to manufacture the drug before full approval occurred.
you can see timelines here: https://www.bbc.com/news/health-55056016 https://www.bbc.com/news/health-55056016
tldr: nothing skipped; however it was compressed.