Samumed Sm04554 Results Normalized To Baseline
- Thread starter hypetraintime
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You sound like a religious priest. Nothing to back up what you are saying but talking about faith and turning down facts by calling sciences pessimistic.
I guess you are new here with only 4 posts to support your opinion and all in that thread. Your credibility based on your contribution seems a bit light compared to the man you are criticising.
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I'm not turning down facts, i'm turning down speculations about a drug for which we don't even know the full MOA yet, so i really don't understand how we could possibly forecast its efficacy.
Facts are clinical studies and publications. Being so easy to determine the effectiveness of a drug, pharmaceutical companies wouldn't be wasting time with clinical trials which are known to be extremely energy, time, and money consuming.
That's what we should do, wait a few months for results, make as many theories as we want but we should avoid mistaking speculating theories with facts. Phase 3 results will tell the truth about this drug, and maybe pegasus will be right, and i'll be the stupid priest, maybe not.
Those are not mutually exclusive
Flamingflaps
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Any guesstimates as to when this might be released? Sometime 2022?
Yes possibly. But maybe 5 years
If everything goes well 2022 seems a down to earth date, considering it is a topical medication things should flow pretty easily.
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- 1,242
There is no way FDA and EMA approves this before Turkey, if they are going to release it there..
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Could be offered much cheaper than in Europe and USA. For example you get Avodart (Dutasteride) without prescription for just 39 Turkish Lira, equals 5,2$ atm. Fingers crossed the results are good enough to release it, approvement is the easiest part, especially if they already in contact with the local Ministry of Health.This is an interesting piece, they definitely want to get it on the market in Turkey. (for people who still doubt the intentions of samumed)
Samumed SM04554 Trial In Turkey - Follicle Thought
SM04554, a Wnt activator from Samumed, is currently the only new drug worldwide at a phase 3 trial for androgenic alopecia. Last month, Samumed’s CEO Osman Kibar was featured in a Fierce Biotech article which covered Samumed’s various programs for oncology, arthritis, and of course – alopecia...www.folliclethought.com
(from 09/2019)
I had reached out to a Patient Advocacy Associate at Samumed who helps keep patient groups updated on treatment progress. On a side note, it’s an honorable deed for Samumed to have such a person on staff at this time. I received this response from the Samumed associate regarding the current trial for SM04554 and its implications for approval:
“Thank you for your question regarding SM04554 and the phase 2/3 trial being conducted in Turkey. Based on our pre-trial meeting with the Ministry of Health in Turkey, if the trial meets its primary endpoints, the data would support a marketing application in Turkey. Further, the trial also supports our IND with the FDA. We have not yet had an end-of-phase 2 meeting with the FDA. Based on the data from the trial, we would determine whether to have such a meeting to discuss with the agency what further data and trials would be necessary to support an NDA here in the United States.”
For clarity, the current trial in Turkey could allow approval in Turkey only, while also supporting the data package for US FDA approval. As stated clearly above, there is potential that a further trial may be necessary to reach the US market. While this news may not be considered optimal for US residents anticipating SM04554, it’s certainly better to find out now than in 2021. Based on previous trials for SM04554, safety should be a nonissue. We certainly hope the efficacy results support the drug to get to the US in the shortest amount of time. One interesting note to end upon is the current phase 3 trial is testing two different concentrations of SM04554, 0.15% and 0.25%. With such a large number of subjects in this trial (625), identifying the optimal treatment dose will be obvious and support the best version of SM04554 for market release.
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an appropriate medical congress like?
I am sure it refers to FDA/EMA i.e., regulatory authorities.
I did a quick google search and didn't see anything on "turkey medical congress". Also, if I am not mistaken they may be responding from Turkey thus a language barrier may also be an issue. I don't think it is something to read too much into.
Also, why would they submit it to a medical congress like a conference versus the regulatory authorities for approval.
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The guy that asked the question is also a Turkish guy, could have asked in turkish too, so the language barrier, at least at the side of Samumed shouldn't be a problem.
For the congress: Promotional ideas should be the first to name, it would be a sensation if something is going to launch after decades. Sure FDA approval and an announcement would be nice, but FDA ain't announcing something with worldwide needs except COVID treatments..
Maybe one of these: Medical Conferences in Turkey 2021/2022/2023 (conferenceindex.org)
It is normal to present data from trials at events.