Bayer Prolactin Receptor Antibody For Male And Female Pattern Hair Loss

RolfLeeBuckler

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Advantages of clinical trial in Australia :

“Cost – In comparison to US and Europe, Australia is 30% lower in study budgets. If R&D tax incentives are applicable, the cost advantage climbs to over 50%.

Incentives – Australia has the highest tax incentive for medical research and clinical trials in the world. Australia offers a generous 43.5% cash refund for clinical trials conducted in Australia if the applying country has a global revenue of less than 20M AUD.

Investigational New Drug (IND) not a pre-requisite – One of the major advantages of conducting clinical trials in Australia is that there is no need for an approved US FDA IND for initiating clinical studies. Clinical studies can be initiated in Australia at any time before or during the IND application process and then the data from these studies supplemented to the application, thus leading to a tremendous advantage of saved time. We have witnessed companies advancing directly in to Phase II at the time of IND approval since all Phase I studies were completed in Australia by the time IND approval was secured. This has been possible due to confidence in the very high quality of data generated for clinical studies in Australia.
But in this case hope Medicine has IND Approval For Phase II studies in US. So they should move in this fuc.king Phase II Trial as planned
 

trialAcc

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Zon Ama

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Any news on that? Will it be announced when there are enough people for the trials in Australia?
 

ppma

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If the trial renders positive results, just hoping that the next step towards market goes through the mRNA pathway. Creating monoclonal antibodies is a expensive process, but the antibody sequence could be translated into mRNA for its production inside the body.

(https) pubmed.ncbi.nlm.nih.gov/30795778/
 

RolfLeeBuckler

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If the trial renders positive results, just hoping that the next step towards market goes through the mRNA pathway. Creating monoclonal antibodies is a expensive process, but the antibody sequence could be translated into mRNA for its production inside the body.

(https) pubmed.ncbi.nlm.nih.gov/30795778/
So in the mRNA pathway When the product could be commercialized?
 

ppma

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So in the mRNA pathway When the product could be commercialized?
Couldn't tell really, but if the monoclonal antibody demonstrates efficacy (phase 3), then the mRNA version should undergo all the testing and trial phases since it would be a different product... Realistically, I guess that we would all be slick bald when a supposed release of an mRNA BAY/HMI-115 reached the market.

My wish concerns only money and logistics only.
 

Dimitri001

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If the trial renders positive results, just hoping that the next step towards market goes through the mRNA pathway. Creating monoclonal antibodies is a expensive process, but the antibody sequence could be translated into mRNA for its production inside the body.

(https) pubmed.ncbi.nlm.nih.gov/30795778/
How would an mRNA approach work here? Doesn't mRNA tell cells to produce proteins? Or is an antibody a protein - pardon my ignorance.

Also, I wonder if Bayer's patent would permit someone to go down the mRNA route.
 

RolfLeeBuckler

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It is all nonsense we Are discussing about. Phase 1 just started in Australia. We will hear about the results in Fall/winter of 2023 and See whether they start a Phase 2 in US in 2024.

until then we won‘t hear anything of Hope Medicine so there is Nothing to discuss unfortunately until end of 2023. See you Next Year!
 

Otrebor

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I hope this is not the case and phase 2 starts this year. this industry is cursed or just sucks. it is impossible to think that ineffective and probably harmful vaccines have passed in a year and that for these things the fda and the financiers make so many problems.
yes of course in 25 years new things have been discovered but always only the hormonal side is targeted.

if this is long delayed, fails or has too dangerous side effects, it will be easier to imagine the end of industrial society rather than the end of baldness.
 

pegasus2

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It is all nonsense we Are discussing about. Phase 1 just started in Australia. We will hear about the results in Fall/winter of 2023 and See whether they start a Phase 2 in US in 2024.

until then we won‘t hear anything of Hope Medicine so there is Nothing to discuss unfortunately until end of 2023. See you Next Year!
The trial is already recruiting. It's only 6 months. What makes you think it will take 18 months to get results?
 

RolfLeeBuckler

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The trial is already recruiting. It's only 6 months. What makes you think it will take 18 months to get results?
The Status of the trial is „Not yet recruiting“.

We could be happy If we hear something und end of 2023. The study completion is in March 2024 so Maybe we will get the results in Summer 2024…

These Are the Dates For the Phase I Trial:

Estimated Study Start Date :April 2022
Estimated Primary Completion Date :July 2023
Estimated Study Completion Date :March 2024

There is No reason to believe we get the results earlier then it is officially announced on clinicaltrials.gov unfortunately
 

Zon Ama

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We could get information about it earlier. What about the Reddit thread? Some guys wanted to participate. Do you have any information on that? We only need one dude to participate to see if it works.
 

RolfLeeBuckler

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We could get information about it earlier. What about the Reddit thread? Some guys wanted to participate. Do you have any information on that? We only need one dude to participate to see if it works.

the Point i made was about getting the product For yourself. Yes, it would be Good to hear about brilliant results of reddit Users who Are in this Trial But i don’t Want to jerk off on their pictures i Want to get this treatment this year and my Full Head of hair Back
 

Zon Ama

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I understand. But if we see that it really works on humans like it does on monkeys, we can start saving :D
 

pegasus2

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The Status of the trial is „Not yet recruiting“.

We could be happy If we hear something und end of 2023. The study completion is in March 2024 so Maybe we will get the results in Summer 2024…

These Are the Dates For the Phase I Trial:

Estimated Study Start Date :April 2022
Estimated Primary Completion Date :July 2023
Estimated Study Completion Date :March 2024

There is No reason to believe we get the results earlier then it is officially announced on clinicaltrials.gov unfortunately
Those dates don't mean anything. They're just there because they have to put something, and they'd rather give themselves extra time than not enough. Dr. Sinclair who is conducting the trial has stated that it is already recruiting. Anyone who lives in Victoria should apply www.sinclairdermatology.com.au There is no placebo arm, so you're guaranteed to get the antibody if you get in.
 

pegasus2

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the Point i made was about getting the product For yourself. Yes, it would be Good to hear about brilliant results of reddit Users who Are in this Trial But i don’t Want to jerk off on their pictures i Want to get this treatment this year and my Full Head of hair Back
That was never going to happen. Their optimistic target for commercialization was 2024 before they had a 6+ month delay getting a phase 2 trial going
 

RolfLeeBuckler

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That was never going to happen. Their optimistic target for commercialization was 2024 before they had a 6+ month delay getting a phase 2 trial going
If they had started Phase II trials in Europe i would have Good chances to get my hair back this Year.

Can you please Tell me Why they don’t have a Placebo? Isnt that Duty to do that?
 

Zon Ama

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So what is the overall sentiment on this then? I am really thinking about getting a hair transplant now and then to thicken up/maintain with HMI-115 in the future (even if it will be available later than 2025) as I am not going to take finasteride.
 
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