Why Are More People Not Talking About Samumed?

byebyehair

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If i read this correct SM04554 is in phase 2 on the clinical trial side.

source: https://clinicaltrials.gov/ct2/show/NCT03742518?term=samumed&rank=6
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But on the webside of samumed the pipeline chart shows phase 3 for Androgenetic Alopecia.

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But than again the press release says phase 2/3 trial.
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That means either the phase 2 is just an opertunity and if the results are good they take it as phase 3. Which would mean mid 2020 result are available so best case scenario mid 2021 the treatment is available. If they really do a phase 2 trial with the active ingredient we should wait till 2024 at least to see the product.

Maybe that is the reason why not so many people are talking about that.
 

luen12

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From what I‘ve read a phase 2/3 is a combined trial with 2 stages in order to speed up the development. They start with stage 1, do an interim analysis to see whats effective and what is not, and then immediately start stage 2 with the optimized treatment. After that they use the data of both stages to draw a final conclusion. I think it totally makes sense for them because they still dont know which dose works best (as the lesser concentration had better results than the higher concentration in the previous phase 2 trial). Probably they try to find out the best dose first and then start the second stage (which counts as phase 3) with only one concentration. So ideally, if all goes well, this could be the pivotal trial before applying for approval. But however, I believe it could take longer than a normal phase 3 trial.
 
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Jakejr

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Samumed isn’t talked about because it’s like most of other topicals, just doesn’t work like we all hope. worth trying, but IMO it’s not a standalone. Might be add-on to a regimen.
 
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