Samumed Sm04554 Results Normalized To Baseline

[MrV88]

tüm ülkeler zor bir ekonomik durumdadır. Türkiye'nin bu ilacı onaylaması için uzun süre beklemesi gerektiğini düşünmek istemiyorum. İlaç tarif edildiği gibiyse satış rekorları kırabilir

Tabiki zor durumda ama böyle bir ilaç için millet böbreğini satar desem yeri var. Madem sağlık bakanlığı ile çalışıyorlar ve o araştırmalar Türkiye'de yapıldı ozaman orada çıkarmak çok mantıklı olur, tabiki Amerika'daki fiyatı isteyebilir mi yoksa öyle düşünüyorlar mıdır bilemem.

https://www.find.com.tr/Company/samumedturkeyilacvekozmetikticaretanonimsirketi

Samumed Turkey was founded 22. may 2014 and given approximately 61k$ at founding.

 

[Felippe]

İlaç aşırı pahalı olmadığı sürece, pahalı olabilir. Birçok takviye, losyon kullanıyoruz. Sanırım hepsini bitirip bu işi sadece bu losyonu ve besin takviyesi alarak halledebiliriz.

 

[MrV88]

İlaç aşırı pahalı olmadığı sürece, pahalı olabilir. Birçok takviye, losyon kullanıyoruz. Sanırım hepsini bitirip bu işi sadece bu losyonu ve besin takviyesi alarak halledebiliriz.

Anladığım kadar losyon olarak çıkacak, çoğu tedaviler öyle olacak gibi. Besin takviyesi gerek olduğunu düşünmüyorum, şu ana kadar sırf 3 aylık bilgiler var, önemli olan gelecek veriler ve bir sene sonraki sonuçlar.

 

[Will Be an Egg in 5 years]

I just hope it works.

 

[oralminoxidil]

Işte anlamadığım nokta o, niye diyor Türkiye'deki piyasaya sunma prosedürü nasıl olacağını bilmiyorum. Sonuçta orada yapılmış faz 3 çalışması kolaylıkla sonuç alınıp, oyaylatip Türkiye'de satilabilir. Avrupa piyasasını bile buradan besleyebilirler.

Edit: If you follow these profiles it seems like the company is more or less in Turkey since 2014 https://tr.linkedin.com/in/mehmet-samikoglu-5b580aa3

The trials were conducted or at least some members from at the Ondokuzmayıs University (19.May) helped out for the trials

Prof. Dr. Nilgün ŞENTÜRK was assigned for leading the trials at 18.11.2018 till 01.05.2020

Link ain't working somehow, this is the Turkish text:
T.C. ONDOKUZ MAYIS ÜNİVERSİTESİ YÖNETİM KURULU TOPLANTISI KARAR TARİHİ TOPLANTI SAYISI KARAR SAYISI 08.11.2018 35 2018/690-701 KARAR NO: 2018 – 692 Tıp Fakültesi Dermatoloji Anabilim Dalı Öğretim Üyesi Prof. Dr. Nilgün ŞENTÜRK’ün, Samumed, LLC ve Samumed Turkey İlaç ve Kozmetik Ticaret A.Ş. adına OMEGA Araştırma Organizasyon Eğitim Danışmanlık Ltd. Şti. tarafından yapılacak olan “Antrogenetik Alopesi Bulunan Erkek Hastalarda %0.15 ve %0.25 Konsantrasyonunda Topikal SM04554 Solüsyonunun Etkinliği ve Güvenirliğinin Değerlendirildiği Çok Merkezli, Randomize, Çift Kör, Plasebo Kontrollü Çalışma” kapsamında Samsun Teknoloji Geliştirme Bölgesinde görevlendirilmesi konusu görüşüldü. Yapılan görüşmeler ve değerlendirmeler sonucunda; Tıp Fakültesi Dermatoloji Anabilim Dalı Öğretim Üyesi Prof. Dr. Nilgün ŞENTÜRK’ün, Rektör onayı tarihinden itibaren 01.05.2020 tarihine kadar Samumed, LLC ve Samumed Turkey İlaç ve Kozmetik Ticaret A.Ş. adına OMEGA Araştırma Organizasyon Eğitim Danışmanlık Ltd. Şti. tarafından yapılacak olan “Antrogenetik Alopesi Bulunan Erkek Hastalarda %0.15 ve %0.25 Konsantrasyonunda Topikal SM04554 Solüsyonunun Etkinliği ve Güvenirliğinin Değerlendirildiği Çok Merkezli, Randomize, Çift Kör, Plasebo Kontrollü Çalışma” kapsamında; 4691 sayılı Teknoloji Geliştirme Bölgeleri Kanunun 7’nci maddesi ile Ondokuz Mayıs Üniversitesi Öğretim Elemanlarının Teknoloji Geliştirme Bölgelerinde Görevlendirilme ve Şirket Kurabilmelerine Dair Yönetmeliğin 5 ve 7’nci maddeleri uyarınca; asli görevini aksatmamak kaydıyla Samsun Teknoloji Geliştirme Bölgesinde yarı zamanlı görevlendirilmesine ve Üniversite Yönetim Kurulu olumlu görüşünün Rektörlük Makamına arzına oy birliği ile karar verildi

i am a medical student at this university

 

[Tom4362]

He says he has no clue about the approval in Turkey

Lol, thats weird
Thanks for the translation though

 

[Felippe]

i am a medical student at this university

Super, do you have any additional information about the studies?

 

[Felippe]

Anladığım kadar losyon olarak çıkacak, çoğu tedaviler öyle olacak gibi. Besin takviyesi gerek olduğunu düşünmüyorum, şu ana kadar sırf 3 aylık bilgiler var, önemli olan gelecek veriler ve bir sene sonraki sonuçlar.

thanks for the translation

 

[oralminoxidil]

Super, do you have any additional information about the studies?

I am currently in another city due to covid. I'm sure there are some people in the forum who are in the same city right now. the professor works in a private practice. If I were there, I would go and make an appointment, maybe someone would do that for us. Also, nobody knows anything in Turkish forums. Either the drug is really ineffective or no one can say anything because of very strict rules.

 

[Felippe]

I am currently in another city due to covid. I'm sure there are some people in the forum who are in the same city right now. the professor works in a private practice. If I were there, I would go and make an appointment, maybe someone would do that for us. Also, nobody knows anything in Turkish forums. Either the drug is really ineffective or no one can say anything because of very strict rules.

I got it buddy, thanks

 

[pegasus2]

I've read most of it.

Sounds more like a paranoid (ex) employee than anything else. Also no proof for his claims besides his words.

And if Samumed tampers with their clinical data, then why did one of their phase II trials fail? Doesn't make any sense.

But I'm also not keen on defending pharma companies, I know and have seen enough of the industry... So yes the guy could be right and completely honest but it's hard to judge these things especially when he brings no proof besides his words.

Maybe, but he does make some good points, and it's rather difficult to prove a sophisticated fraud like that. You just have to wonder why they do certain things like performing their trials in house, or raising funds solely from individuals rather than investment banks that would demand more rigid oversight. I don't think they are fabricating data outright, but would you be surprised if they are manipulating the trial design and stats to make it appear better than it is? If their former employee is right this would be a soft fraud, in which they have real drugs and conduct real trials, it's just that the drugs are ineffective and they know it. You can dupe more investors by running trials with legitimate but ineffective drugs than by not running any trials. Time will tell, but don't be surprised if this company just keeps running trials until the money stops coming in, but never releases a product outside of Turkey.

I only say all this because people are pinning their hopes on this drug, and they should know it's a longshot. If you're hoping to avoid finasteride and minoxidil by waiting for SM you may regret it.

 

[frank33]

Maybe, but he does make some good points, and it's rather difficult to prove a sophisticated fraud like that. You just have to wonder why they do certain things like performing their trials in house, or raising funds solely from individuals rather than investment banks that would demand more rigid oversight. I don't think they are fabricating data outright, but would you be surprised if they are manipulating the trial design and stats to make it appear better than it is? If their former employee is right this would be a soft fraud, in which they have real drugs and conduct real trials, it's just that the drugs are ineffective and they know it. You can dupe more investors by running trials with legitimate but ineffective drugs than by not running any trials. Time will tell, but don't be surprised if this company just keeps running trials until the money stops coming in, but never releases a product outside of Turkey.

I only say all this because people are pinning their hopes on this drug, and they should know it's a longshot. If you're hoping to avoid finasteride and minoxidil by waiting for SM you may regret it.

If this same employee had said something good about this drug you would have not believed him, saying his words without evidence mean nothing.

We are all biased in this thread, some for the best, and some (you) for the worst.

Time will tell.

 

[pegasus2]

If this same employee had said something good about this drug you would have not believed him, saying his words without evidence mean nothing.

We are all biased in this thread, some for the best, and some (you) for the worst.

Time will tell.

That's where you're wrong, I'm simply being objective. I'm open to anything positive about the company too. I just see a lot to be skeptical of here. I'm much more optimistic about Bayer, Follica, Surrozen, Tissuse, and Stemson.

I do wonder why virtually all of your posts are in this thread pumping this company. Do you work for them? Why so much interest in this particular company, but no interest in anything else?

 

[Felippe]

İşte burada yanılıyorsun, ben sadece objektif oluyorum. Şirket hakkında olumlu olan her şeye açığım. Burada şüpheci olacak çok şey görüyorum. Bayer, Follica, Surrozen, Tissuse ve Stemson hakkında çok daha iyimserim.

Neden neredeyse tüm gönderilerinizin bu şirketi pompalayan bu başlıkta olduğunu merak ediyorum. Onlar için mi çalışıyorsun? Neden bu özel şirkete bu kadar çok ilgi duyuyorsunuz ama başka hiçbir şeye ilgi duymuyorsunuz?

Faz 3 çalışmasını bitirmiş bir ilaç olduğu için ilgilenmemiz normaldir

 

[progresiwe]

pegasus stupid

 

[pegasus2]

Where are all these Turks coming from all of a sudden?

 

[Tom4362]

Where are all these Turks coming from all of a sudden?

They feel exposed

 

[oralminoxidil]

Bu Türkler birden bire nereden geliyor?

We come from asia

 

[trialAcc]

Lol, what am I reading...

Yes one of samumed's osteoarthritis phase II trials "failed" but that doesn't mean Samumed is dropping it, there are phase III trials underway.

Biosplice

And RU not going to market could be because of many reasons. Patent rights for example:

ru-58841.com -&nbspru 58841 Resources and Information.

ru-58841.com is your first and best source for all of the information you’re looking for. From general topics to more of what you would expect to find here, ru-58841.com has it all. We hope you find what you are searching for!

www.ru-58841.com

the patent for RU58841 was already quite old when the second clinical trial was finished. If a company would go forward to bring RU58841 to the market then it would only have a short amount of time to generate revenue before other companies could compete and create generic versions.

Also the company behind RU valuating the hairloss market at only 200 million was 20 years ago, I don't need to tell anyone here how important appearance for a man is these days. The market is MUCH bigger than that these days.

But I believe they dropped RU because of safety risks. Also many guys on this forum experiencing sides from RU, especially heart problems. (recent thread: https://www.gourmetstylewellness.com/intera...tions-from-using-ru58841.130225/#post-1923685 )

https://www.gourmetstylewellness.com/interact/threads/ru-58841-human-safety-info.1315/

RU trialling was dropped due to safety concerns over systemic absorption - here's the snippet:

"Furthermore, the absence of a full toxicological report on RU-58841 in any species and the lack of human clinical data has led us to the assumption that product development has been abandoned."

Comparing SM04554 to RU's situation back in the day doesn't make any sense, too many different variables.

Also comparing Samumed to Theranos? Really now? Lol!

Anyway, being sceptical is good. We've been burned enough. But Samumed is no fraud, there is absolutely zero evidence that they are. It's all wild speculation based on nothing.

I'm not saying those guys are not having sides, but I don't think heart fluttering alone would have derailed this trail, so it's a pretty inconclusive call to say that the drug was dropped for safety concerns. Minoxidil gives me heart palpitations and fluttering from time to time, and is a known minor side effect, yet the drug is sold over the counter.

I don't use RU, but every drug has both minor and major sides. Every story I've seen about the heart palpitations that has gotten their heart checked (been 2-3 now) has said that there was no detectable damage when they went to the doctors and hospital in one guys case. That being said, I wouldn't take a drug every day for the rest of my youth that has 0 established side effect profile, but I'm just pointing out that there is more of an argument to be made on the financial side of things then for health side of things. Closing to being off patent and a small estimated market is easily a drug trial killer.

 

[trialAcc]

Again, I didn't say it was a fraud. Stop putting words in my mouth. If your investing strategy is to follow people who you think are good investors, then you're going to go bankrupt. Do I need to post a list of the "smart" people who invested in Enron? I'm seeing the same arguments in this thread that people used to use in the Brotzu thread. "ZOMG you're an idiot pegasus, Fidia is a huge company they wouldn't back a loser, and Dr. Brotzu is a respected doctor, he would never risk his reputation on a fraud."

Samumed's cancer drugs have more potential than this. Maybe one of them will be a success, and the company will make it big. Even in that event, that doesn't mean anything for their hair loss drug. This drug has to be evalueted on its own merits, and those merits don't justify the hope I'm seeing from some of you guys.

Ya everyone is disregarding what you are saying because you have literally no basis for your claims. What exactly about the 90 day trial mostly geared towards safety didn't do it for you? And further, is a 24 month trial not a very effective medium for pushing the drug to market? I have much more doubts about the garbage that Casseopia is trying to pull with a sham of a 6 month phase 3 trial the most comprehensive phase 3 trial completed in this space since Propecia.

If you're evaluating it on it's own merits then justify/disclose what those merits are. We all know that 99% of hair loss treatments take a lot longer then 90 days to show efficacy, but if you have some other insight into why this drug won't succeed or about the data that's going to be released then please share. Otherwise you have the same info as the rest of us and are coming from a position of bias as you've already written the company off with skepticism.

And you did liken it to fraud, you said that it was more likely to Theranos then Regeneron. Theranos committed fraud for years to get funding.