Samumed Sm04554 Results Normalized To Baseline

[TurboFixer]

They value themselves at 12 billion, it's not an independent valuation so take that for what it's worth which is nothing. The CEO admits that if they did an IPO the market wouldn't value them at anything close to 12 billion. None of their drug candidates have proven to be successful yet, and this one is still questionable. Samumed seems more like the next Theranos than the next Regeneron. The CEO is a slick salesman, but I don't trust them.

If there is any field where I would expect Theranos style grifting it would be the fkn Wild West snake oil infested hair loss field

 

[trialAcc]

So you think startups operate on a binary of completely legit or complete fraud with nothing in the middle. You're free to have whatever opinion you'd like but I'm just letting you know that it's a bad take. I've yet to see a successful phase 3 from Samumed. Until that happens they aren't worth 12 billion. I'm not saying they don't have real drugs with potential, but I think they're more interested in running trials just to raise funds than to actually get their drugs approved. There's no evidence that they truly believe any of their drug candidates will be successful. They don't need them to be, they're already getting rich off of dumb investors. If you feel so strongly about them go be one of those investors. Venture capital won't touch them.

Based on what evidence though, is my point. They are doing what literally any start-up biotech company does, ever, developing a platform in which they can expand into a pipeline and eventually push drugs to market or get acquired. I would understand the hesitancy if this was pre-clinical research, but with basically half their core pipeline in the clinic and already moved passed safety trials they are already putting their money where their mouth is by driving drugs to market.

I also don't really understand why you are saying VCs wont touch them, they raised almost 500 million in 2018 through private equity/VC in addition to 200~ million a year or two prior.

 

[trialAcc]

If there is any field where I would expect Theranos style grifting it would be the fkn Wild West snake oil infested hair loss field

Yeah but this is my point, they have 8 programs in clinical trials right now. 1 is hairloss, the rest is cancer, degenerative disk disease, pulmonary fibrosis, tumors and alzheimer's, meaning that the science behind their WNT pathway program has been thoroughly proven to have merit behind just a single application.

This isn't a start-up pretending they can cure hairloss because their compound used on a mouse grew hair. Even if the drug doesn't prove to be worth it or effective, it's not snake oil.

 

[pegasus2]

Our existing investors participated about ~15-20% of this round, the rest are new. And we went with private capital again (family offices, high net worth individuals, and sovereign funds), no VC/PE (except Vickers).

The investment banks are not convinced their drugs will work. That isn't an argument against them imo. I'm just saying that their valuation and the 500MM they raised doesn't mean much either. It sounds really impressive when you say they're valued at 12 billion, but raising 500 million is less unusual than the valuation. It would be impressive if that was just for a hair loss drug, but as you say they have a lot of more interesting drug candidates.

How much money have they raised since the arthritis drug failed? I don't think they will have much success raising money now until something shows success, and the phase 2 data from the hair loss drug isn't going to cut it.

I'm not the only one saying this btw. A lot of people in finance are skeptical of them, and balk at the valuation of 12 billion. That valuation does raise a big red flag. I think the odds of them even bringing this to market are 50/50 at best. We will see how phase 3 firms out, but I'm not expecting anything spectacular.

 

[frank33]

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.

I think comparing this to Brotzu's cosmetical thingy is deceiving at the very least.
SM04554 has completed 3 clinical studies, and the last one is the biggest in the hair loss field since propecia.

 

[pegasus2]

I think comparing this to Brotzu's cosmetical thingy is deceiving at the very least.
SM04554 has completed 3 clinical studies, and the last one is the biggest in the hair loss field since propecia.

You're right, Brotzu Lotion was actually released, this probably never will be.

 

[pegasus2]

Nobody on this website understands nuance. Smh

 

[Felippe]

Herkese merhaba, uzun zamandır bu sayfayı takip ediyorum. İngilizcem için özür dilerim Eğer yanlış anlamazsam, ilacın piyasaya çıkış tarihi Amerika için 2022 yazının başlangıcı.

 

[Felippe]

Osman Kibar'ın 2 ay önce yayınlanan videosunu buldum. Yunan olduğum için biraz Türkçe biliyorum. Bu yıl 3 ilaç üçüncü deneyi bitirecek. Kadın ne kadar yakında satışa çıkacağını soruyor. 2022 yazının başlangıcı yazıyor. Ama o bundan sadece sac için bahsetmiyor. Ama en yakın tarih 2022 yazının başlangıcı. Cümleleri yanlış anlamadıysam bu şekilde tercüme ettim. Videoyu aşağıya koyuyorum

 

[Felippe]

 

[MrV88]

English guys, what is being said in the video? Anything interesting?

A video from 2 months ago, the women asks when this would be available and Kibar says approximately early summer 2022 in USA (earliest estimate) and Phase 3 trials for 3 treatments will finish soon/this year.

 

[Felippe]

A video from 2 months ago, the women asks when this would be available and Kibar says approximately early summer 2022 in USA and trials for 3 treatments will finish soon/this year

Does it say when it will air in Europe? or turkey

 

[pegasus2]

I'm not saying the company is a fraud. This former employee is though, and he says Tan is in on it. He claims the business model is for the CEO and Tan to bilk individual investors. https://medium.com/@adamjschindler/...ht-down-a-pharmaceutical-company-ee8a1cf4c4b3

 

[nick123]

I'm not saying the company is a fraud. This former employee is though, and he says Tan is in on it. He claims the business model is for the CEO and Tan to bilk individual investors. https://medium.com/@adamjschindler/...ht-down-a-pharmaceutical-company-ee8a1cf4c4b3

Do you reckon Samumed are or would fabricate the safety and efficacy data of SM04554 then?

EDIT: Holy f*** I just read that entire article, it's long but extremely worrying that in 2021 a company like Samumed can get away with data manipulation for safety and efficacy. If it's true they were doing this for their osteoarthritis drug, then there's no reason why they wouldn't do this for SM04554.

 

[frank33]

Trust me, this will be avaiable in turkey in a matter of months. Osman needs to hop on SM quickly, he's deteriorating pretty fast

 

[MrV88]

Does it say when it will air in Europe? or turkey

After 59 minutes

Within 9 months all phase 3 will be done, they plan to file in their data in October to get an accelerated FDA Approval. Should be done by 2. quarter 2022 in America then. He ain't sure if Turkey will follow Europe for approval, if yes it will take much longer and they have to conduct new trials in Europe. If Turkey counts FDA approvement as sufficient it's just paperwork and they could get it on the market after FDA approval and filing in the needed documents at the ministry of health in Turkey. He says he has no clue about the approval in Turkey, don't get why he says that although their Phase 3 is in Turkey. either way their main goal is FDA approval and US market. Problem is it ain't clear which of those treatments he mentions, but they plan to bring more or less all market ready by 2022

 

[nick123]

Have Samumed ever released any before and after photos of SM04554?

 

[Felippe]

1: 13'ten sonra

9 ay içinde tüm aşama 3 tamamlanacak, hızlandırılmış bir FDA Onayı almak için Ekim ayında verilerini dosyalamayı planlıyorlar. O zaman Amerika'da 2022'nin 2. çeyreğine kadar yapılmalıdır. Türkiye'nin onay için Avrupa'yı takip edip etmeyeceğinden emin değil, eğer evetse çok daha uzun sürecek ve Avrupa'da yeni denemeler yapmak zorunda kalacaklar. Türkiye, FDA onayını yeterli sayarsa, bu sadece evrak işidir ve FDA onayı ve Türkiye'deki sağlık bakanlığında gerekli belgeleri dosyaladıktan sonra piyasaya sunabilirler. Türkiye'deki onay konusunda hiçbir fikrinin olmadığını söylüyor, neden 3. Aşama Türkiye'de olmasına rağmen diyor. her iki durumda da ana hedefleri FDA onayı ve ABD pazarıdır. Sorun şu ki, bu tedavilerden hangisinden bahsettiği net değil, ancak 2022'ye kadar tüm pazarı hazır hale getirmeyi planlıyorlar.

Sanırım bu deneyler Sağlık Bakanlığı gözetiminde yapıldı. Türkiye'de ilk satılacağını düşünüyorum.

 

[MrV88]

Sanırım bu deneyler Sağlık Bakanlığı gözetiminde yapıldı. Türkiye'de ilk satılacağını düşünüyorum.

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

 

[Felippe]

İşte anlamadığım nokta o, niye diyor yerine sunma prosedürü nasıl yaş bilmiyorum. Sonuçta sonuçta yapılabilir faz 3 araştırılabilir sonuç alınıp, oyaylatip Türkiye'de satilabilir. Avrupa piyasasını bile buradan besleyebilirler.

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