Samumed Sm04554 Results Normalized To Baseline

hypetraintime

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Given the WNT information, I would not touch SM04554 unless it was directly supplied by Samumed. You have no idea what they are giving you otherwise. Especially since Samumed hasn't released much information about how it works as well.
 

Janko

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So treatment will only be available late 2021 or 2022. I thought it would be earlier like late 2020
FDA approval. The trial itself is done in Turkey and the completition date is June 2020. Samumed also stated they will communicate during the trial with FDA how they should proceed further. So, with a little bit of luck the treatment could be released in early 2021 in Turkey and maybe even in Europe. If they will want it to be released everywhere only after FDA approval I would guess that they will release it late 2022/early 2023.
 

wislow9

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WAY have a similar role to SM04554 ...
we could be used this while SM04554 will be available 2020/2021
 

MaestroTR

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So, is this a maintenance drug at its best right? Without any sides? We do not hope any regrowth for it, especially for NW3+ guys?

I live in Turkey and can help people who need Samumed, btw.
 

Janko

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So, is this a maintenance drug at its best right? Without any sides? We do not hope any regrowth for it, especially for NW3+ guys?

I live in Turkey and can help people who need Samumed, btw.
SM has a higher potential, than just maintenance. There was overhype expectation in 2016 before they released phase 2 results. People expected, that it will do miracle within 90 days. The result was 10% hair count increase and people got disappointed. At its best it COULD potentionaly give lets say 30 % increase in hair count after 12 months. I doubt, that SM will be cure, but it surely won't be just maintenance drug. That is also the main reason Samumed is going forward with it.
 

Janko

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Living in Europe, I'll book the cheapest flights to Istanbul. I am sure Turkish docs will be lenient.
Lets hope, that EMA will consider their trial as sufficient and give it a green light. Non internal drugs usually have faster approval than pills itself.
 

ruffledfeathers

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What is the difference in number of subjects between the 'optimal' group and the 'everyone' group?
 

MrJolly26

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59
Seems like this is going to be the only new treatment that we will be able to buy any time soon.

So, do you think will we see photos before the ending of the trial? Or even before September?

Since the trial will end in June, it could be possible... Right? ;)
 

SamFT

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I don’t know if anyone saw this but on samumeds phase 3 clinical trial it does say the drug is US FDA regulated. So maybe after phase 3 they will apply for approval in both turkey and US?
 

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FilthyFrancis

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Bad news.

Looks like clinicaltrials.gov are already betting on a 6-month delay for the phase 3 study.

Estimated primary completion date has just been updated and postponed to Q1 2021...
 

topicalthunder

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Bad news.

Looks like clinicaltrials.gov are already betting on a 6-month delay for the phase 3 study.

Estimated primary completion date has just been updated and postponed to Q1 2021...

Though a delay is bad... they’ve also updated the status from “recruiting” to “active, not recruiting” which is actually a good sign. They are now underway!
 

MrJolly26

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I´m afraid Samumed has been struggling since the very beginning and it seems complicated to ever get this product. Thought it was our only chance in the short term, but here we go again. Delays, and more delays... :(
 
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