Prolactin "minitherapy" with SMI-1 (novel protocol for lowering prolactin locally)

kuba197

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Can you pleite gute us the link about the Fact that only women participated in the Trial?

How is it passable that they can start a Phase 2 trial in men without even doing Phase 1 for them?
Which dangerous Effects could only happen in men but not in women in Phase 2?
Just take into account that for researchers, sexual side effects are not dangerous.
 

RolfLeeBuckler

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How could they possibly know that from a 3 month trial?

I always thought that Phase 1 is For safety. If they only control the patients After 3 months For safety concerns this trial Makes no sense in my opinion...

Phase 2 should be a dosing and a efficacy trials without serious risks For the patients
 

justinbieberscombover

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140838.jpg
 

RolfLeeBuckler

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That doesn't typically get released, anyways it's only 2 years and they were only in the drug for 90 days so it wouldn't prove safety anyway. Even Phase III doesn't prove safety. Drugs have looked safe in all trials then come on the market and killed people

If you had the Choice to participate in Phase 2 trials of HMI-115 would you do that?

What is your opinion of These Treatment regarding dangerous events? I think it is just prolactin receptor, no stem cells no Castor oil. This should be safe i think...
 

trialAcc

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They Did Phase 1 Trial in 2019 do there should be 3 Years data. But Where it is?!
Dude, no one supplies this information. They dose patients for 3 months and ask for patient feedback, test blood for liver/kidney damage, and see if they drop dead. Then they report that data.

Welcome to the global clinical trial process.
 

RolfLeeBuckler

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Dude, no one supplies this information. They dose patients for 3 months and ask for patient feedback, test blood for liver/kidney damage, and see if they drop dead. Then they report that data.

Welcome to the global clinical trial process.
So Replicel was lot more professional then bayer regarding the data review of 5 Years phase 1 Trial
 

RolfLeeBuckler

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Replicel has to keep reporting new stuff to get more money from suckers. Forget you ever heard the name replicel
Hope Medicine raised 65 Million Dollar!!!‘ and i don’t know Where they put the money in. They didnt Start Trial they don’t have a website...
 

Ollie

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Hope Medicine raised 65 Million Dollar!!!‘ and i don’t know Where they put the money in. They didnt Start Trial they don’t have a website...
The investors will be kept in the loop more than the media. They have no benefit of putting on a show like replicel if they don’t need more money - that will come when marketing the drug.
 

scientist_0005

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Yes we don’t Unterstand. Thats why we are in this Forum and ask questions
they are screening for very severe events here that would not permit any further studying of the drug in humans. things like heart failure, death, immediate allergic reactions etc. that is why studying men is not necessary because women and men on a grand scale are very similar genetically and the diffrrences are not going to produce these major adverse events. for more minor effects, the later studies are used for as well as efficacy of course. but with this one they know that if sou inject hmi in a human he wont die within a few weeks
 

scientist_0005

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That doesn't typically get released, anyways it's only 2 years and they were only in the drug for 90 days so it wouldn't prove safety anyway. Even Phase III doesn't prove safety. Drugs have looked safe in all trials then come on the market and killed people
that is because safe drugs can kill people when you are very unlucky and have some sort of predisposition. generally the vast majority of drugs out of phase 3 are save. you also have to differentiate, for a cosmetic condition you may not accept a potential lethal side effect. but if the disease itself is so devastating you may very well accept such drugs and thus they shall be approved for those conditions even if they kill people in the trial, if the overall response is positive and decreases mortality for example.

people also abuse drugs and do not take them as intended.. so sure drugs kill people but its only half of the story.


generally phase 1 is there for a rewson and most major events would have occured there with tbis kind of drug.

i also think they would have occured in the primates as well
 
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