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I feel the same way except I still have faith in MOOGENE Medi, STEMSON Tx , and dNOVOif this treatment is not as effective as it seems, let's get ready for another generation thrown away
I feel the same way except I still have faith in MOOGENE Medi, STEMSON Tx , and dNOVOif this treatment is not as effective as it seems, let's get ready for another generation thrown away
Hopemedicines intention was to do a international multi centre phase 2 in US/EU/AUS (I don’t know why) . But since Australia rejected them to bypass phase 1 they will have to complete phase 1 in Australia and then commence with the original plan . They must be doing it to save costs down the line. We basically got set back 1 year cause of this
I feel the same way except I still have faith in MOOGENE Medi, STEMSON Tx , and dNOVOif this treatment is not as effective as it seems, let's get ready for another generation thrown away
You realize that they can still launch a P2 trial in the USA or EU right? There is no press release with this Aus trial, meaning they probably have other things ready to launch/announce before they start issuing the final press release.if you would like to bring HMI-115 to Market and you got a rejection in Australia and First had to do a Phase I Trial there… would you do the Phase I Trial in Australia or would you do Phase II in US and Europe to bring the product to Market as soon as possible????
it Really is to stupid For me to beliebe this fu.cking sh1t
You realize that they can still launch a P2 trial in the USA or EU right? There is no press release with this Aus trial, meaning they probably have other things ready to launch/announce before they start issuing the final press release.
They are not doing a phase 1 to check if it's worth it, no one does that. Phase 1 is generally 100% safety related.i Hope you Are Right. But i am very nervous… it Doesnt make Sense to start Phase I and immediately After this starting a Phase II Trial in other countries.
It would make Sense:
Option 1: to do Phase I and wait until Trial finished. After then checken the results and think about If it is Worth to start Phase II.
Option 2: to start Phase II in US directly
They are not doing a phase 1 to check if it's worth it, no one does that. Phase 1 is generally 100% safety related.
They're doing a phase 1/2 because Australia clearly declined to allow a P2 to start in their country without data for that dose level or on men at all.
Should email the company* and ask. Obviously Australia is an important market for them as they aren't even doing trials in China yet despite almost guaranteed clearance.yes But Why they start this Australia Trial at First?
they had FDA clearance in US For Phase II Trial! Why Arent they faster in starting the Trial in US then starting in Australia?
I wrote a lot of e mails to the company and got No answersShould email the company* and ask. Obviously Australia is an important market for them as they aren't even doing trials in China yet despite almost guaranteed clearance.
I wrote a lot of e mails to the company and got No answers
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 plannedAdvantages 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.
Shouldn't even post that here, he's going to get spammed by trolls and quit reddit.The subreddit r/HairlossResearch has introduced Professor Rodney Sinclair as a resident expert (announcement). He is on the team of Sinclair Dermatology which is the outfit recruiting for the HMI trial in Australia. Perhaps we could get some info out of him. Thanks to TrichoSearch on Reddit for the tipoff!
So in the mRNA pathway When the product could be commercialized?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/
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.So in the mRNA pathway When the product could be commercialized?