FDA DOC:22 CASE STUDIES WHERE PHASE 2 AND PHASE 3
Post# of 155443
(Total Views: 1126)
Posted On: 07/29/2020 5:19:58 AM
FDA DOC:22 CASE STUDIES WHERE PHASE 2 AND PHASE 3 TRIALS HAD DIVERGENT RESULTS
https://www.fda.gov/media/102332/download
I have been perplexed as to why hold the phase 2 results and announce with phase 3 but after reading this doc from the fda, it is a brilliant move. I am a newbie to all the medical terms and knowledge but it seems that a phase 2 trial is meaningless unless backed by a phase 3 especially if phase 3 shows great results with even more severe patients. Its put the FDA and the world on undeniable notice that leronlimab works without a doubt.
In todays climate with hydro, etc.... any drug that is going to counter that bias needs to prove without any doubt that it works and releasing the data together does not give room for anyone (even shorts) to attack its credibility. It also will force FDA to grant approval given all the number of people getting infected. At the minimal it will expand its emergency access profile in which production and release of leronlimab can increase.
Furthermore it is important to note that NP and Peterson need to be very careful not to damage leronlimabs image here for all the illnesses it can be used for. They need to walk a none threatening line given the political climate covid drugs are in.
Just a newbies thoughts
https://www.fda.gov/media/102332/download
I have been perplexed as to why hold the phase 2 results and announce with phase 3 but after reading this doc from the fda, it is a brilliant move. I am a newbie to all the medical terms and knowledge but it seems that a phase 2 trial is meaningless unless backed by a phase 3 especially if phase 3 shows great results with even more severe patients. Its put the FDA and the world on undeniable notice that leronlimab works without a doubt.
In todays climate with hydro, etc.... any drug that is going to counter that bias needs to prove without any doubt that it works and releasing the data together does not give room for anyone (even shorts) to attack its credibility. It also will force FDA to grant approval given all the number of people getting infected. At the minimal it will expand its emergency access profile in which production and release of leronlimab can increase.
Furthermore it is important to note that NP and Peterson need to be very careful not to damage leronlimabs image here for all the illnesses it can be used for. They need to walk a none threatening line given the political climate covid drugs are in.
Just a newbies thoughts
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