Bayer Prolactin Receptor Antibody For Male And Female Pattern Hair Loss

pegasus2

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I realize that for many this is "only" an aesthetic problem and therefore it is not given relevance. But there are many people who suffer from it on a personal level and I am sure that many who shave their heads and ignore it deep down also suffer from it. It is a question of human dignity, not just an aesthetic problem. If the investors and whoever managed it were not cynical Methuselahs, all this would be clearer. To wait decades for something that could be solved in 2-4 years is absurd.

Now we find ourselves with Australia that rejected phase 2 because Hope medicine wanted to save twice, the first time by doing phase 1 only for women, the second time when it decided to do a single joint phase two in the various countries. This ridiculous and irresponsible management of the company has led not only to delays but also to spending more money, other than saving.
That's overly pessimistic. It is normal to have a single multicenter global phase 2, and increases statistical power. As for only doing one phase 1, HMI isn't the one to blame for that. That trial was conducted by Bayer because they had no plans to use the drug for hair loss. When HMI purchased rights to the drug that changed. If they had decided to start with a phase 1 for hair loss they would still be waiting for that trial instead of having an approval to run a phase 2 in the US. Their choice will get the drug to market faster provided they move forward with the phase 2 in the US without waiting for the Australian trial to complete. No one knows what their plans are so there is no foundation to criticize them on this matter
 

-specter-

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That's overly pessimistic. It is normal to have a single multicenter global phase 2, and increases statistical power. As for only doing one phase 1, HMI isn't the one to blame for that. That trial was conducted by Bayer because they had no plans to use the drug for hair loss. When HMI purchased rights to the drug that changed. If they had decided to start with a phase 1 for hair loss they would still be waiting for that trial instead of having an approval to run a phase 2 in the US. Their choice will get the drug to market faster provided they move forward with the phase 2 in the US without waiting for the Australian trial to complete. No one knows what their plans are so there is no foundation to criticize them on this matter
I hope you are right, and that no more time is wasted on the buttercracy
 

JohnDoe5

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This was covered just 2 or 3 pages back in this thread. People really need to learn to read first and ask questions later
So the Aussies have been given the green light to start a phase 1 study while they have been given the green light to start a phase 2 in the US. Interesting. I suspect they'll start phase 1 in Australia while starting phase 2 in the US at the same time. Of course, I'm not sure of this but it's my suspicion.
 
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pegasus2

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So the Aussies have been given the green light to start a phase 1 study while they have been given to start a phase 2 in the US and Europe. Interesting. I suspect they'll start phase 1 in Australia while starting phase 2 in the US and Europe at the same time. Of course, I'm not sure of this but it's my suspicion.
It might make the most sense to wait three months to see if the dose used in the AUS phase I trial is working. They've probably already dosed the first patient.
 

RolfLeeBuckler

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So the Aussies have been given the green light to start a phase 1 study while they have been given to start a phase 2 in the US and Europe. Interesting. I suspect they'll start phase 1 in Australia while starting phase 2 in the US and Europe at the same time. Of course, I'm not sure of this but it's my suspicion.

where Did you See that they have Been given a green light to start Phase II in Europe? I think only US was mentioned…
 

JohnDoe5

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Unfortunately a Mistake :(
At least the US has authorized the company to go ahead with phase 2. If the company starts phase 2 in the US that means 2 good things for you.

1. If a US phase 2 study proves the treatment works then you might be able to get it early via blackmarket.

2. If a US phase 2 study proves the treatment works it would move to phase 3 in the US and once it completes phase 3 you could fly to America and get the treatment and then go home. Now, if you do it this way, rather than getting it blackmarket, then you would have to stay in America for months until you've used the treatment long enough that the recovery process will continue even after you go home and stop using the treatment.
 

RolfLeeBuckler

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At least the US has authorized the company to go ahead with phase 2. If the company starts phase 2 in the US that means 2 good things for you.

1. If a US phase 2 study proves the treatment works then you might be able to get it early via blackmarket.

2. If a US phase 2 study proves the treatment works it would move to phase 3 in the US and once it completes phase 3 you could fly to America and get the treatment and then go home. Now, if you do it this way, rather than getting it blackmarket, then you would have to stay in America for months until you've used the treatment long enough that the recovery process will continue even after you go home and stop using the treatment.
I have Zero Problem to Stay und US For months to get my hair Back.

do you think that Phase II trials will only be For US residents or will it also be possible For european People of they Stay in the US For the duration of the trial?
 

JohnDoe5

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I have Zero Problem to Stay und US For months to get my hair Back.

do you think that Phase II trials will only be For US residents or will it also be possible For european People of they Stay in the US For the duration of the trial?
I don't know if/when US trials will take place. I've only been speculating about stuff like everyone else. That aside, I don't think that US trial managers will allow people from foreign countries to take part in US trials. IMO the people doing the trials would want to be sure that the participants live close to the study site.

When I said that you might have to reside in the USA for some months I was talking about AFTER trials are over and the treatment is on the US market you might be able to spend some time in America to get the treatment but you might have to stay in American long enough to complete the treatment regimen.
 

Dimitri001

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At least the US has authorized the company to go ahead with phase 2. If the company starts phase 2 in the US that means 2 good things for you.

1. If a US phase 2 study proves the treatment works then you might be able to get it early via blackmarket.

2. If a US phase 2 study proves the treatment works it would move to phase 3 in the US and once it completes phase 3 you could fly to America and get the treatment and then go home. Now, if you do it this way, rather than getting it blackmarket, then you would have to stay in America for months until you've used the treatment long enough that the recovery process will continue even after you go home and stop using the treatment.
Is this plausible? Can random labs manufacture this antibody or is it too technically difficult?
 

Dimitri001

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iirc they have contacted labs regarding HMI but were quoted an amount which was not affordable + it had to be stored in -20C
Oh, that's right. So then they CAN produce it, I guess the question then becomes can they produce it at some reasonable price. I mean we've come to terms now with the likelihood that it's gonna cost a lot of money, 10s of 1000s of $, so could the labs produce it at something like that kinda price is the question now.
 

JohnDoe5

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Oh, that's right. So then they CAN produce it, I guess the question then becomes can they produce it at some reasonable price. I mean we've come to terms now with the likelihood that it's gonna cost a lot of money, 10s of 1000s of $, so could the labs produce it at something like that kinda price is the question now.
I would think the blackmarket price would be cheaper because a lot of the blackmarket chemicals come from countries where labor is less expensive, such as India and China.
 

pegasus2

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Several problems with all the black market speculation. The black market is China. This is a Chinese company. The CCP may not care about infringing upon Western patents, but they probably don't want their own company being undercut. Jimmy Bob in his basement doesn't have the equipment or expertise to manufacture mAbs. It would be hard to find anyplace that has the capability and will actually be willing to skirt the law and sell it to degens on HairLossTalk.com and Reddit.
 

coolio

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IMO the difficulty of producing monoclonals is the main thing standing in the way of black market HMI-115.

If it was easy enough to do, then somebody would be willing to rip off somebody and sell it. If it's not one Chinese company ripping off another then it would be an Indian lab ripping off the Chinese or something. One way or anther it would happen.
 
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