Haha, I am trying to spread some positivity in this thread. Maybe youre right.
clinicaltrials.gov
www.biospace.com
This was covered just 2 or 3 pages back in this thread. People really need to learn to read first and ask questions laterCould someone please explain the below information to me? The 1st link says that HMI-115 is only now preparing to go into a phase 1 trial for hair loss and recruitment hasn't even started yet BUT the 2nd link says that Hope Medicine has been given clearance to start its phase 2 trial with the same treatment and also for hair loss. Since the company was given clearance to start its' phase 2 study that should mean the phase 1 study is completed and the results have been tabulated. I'm confused. Which one of these 2 links is accurate?
ClinicalTrials.gov
Hope Medicine Announces US FDA Clearance for Phase II Clinical Trial of A First-in-class Monoclonal Antibody, HMI-115, in Androgen Alopecia
Hope Medicine Inc. has recently announced that U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for phase II study to evaluate HMI-115, a first-in-class monoclonal antibody drug in treating androgen alopecia.
Yes but now i have a real motivation to make money
))
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
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.
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.
You're right. My mistake.
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.Unfortunately a Mistake
I have Zero Problem to Stay und US For months to get my hair Back.
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.
Is this plausible? Can random labs manufacture this antibody or is it too technically difficult?
iirc they have contacted labs regarding HMI but were quoted an amount which was not affordable + it had to be stored in -20C
the same conditions than actual Covid vaccine, treatment is similar
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.