Samumed Interview w/ Dr. Yusuf Yazici

xyz123

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It's interesting that Samumed is the first presenter and that the conference is for "groundbreaking" dermatological science.

I'm not saying this means that Samumed is definitely a breakthrough but it does seem like these are
positive signs.


Nameless - I think this is extremely positive. Like you, I started to get worried after we never heard anything further from Samumed following their original preliminary announcement in early December indicating that the results from Phase 2 were positive. If they weren't showing pictures, then maybe their statistical benefit wasn't really reflective of a substantial clinical benefit...

But their presenting at the "late breaking research" session at the American Academy of Dermatology changes everything.

Why?

1. Getting to present research at a "late breaking" session is very competitive. There are usually a very large number of submissions (it's the entire dermatology community from around the world that is submitting) and only a select few are chosen for presentation. The conference wants to showcase its most exciting findings at the "late breaking" sessions - there will be lots of press. If the results were mediocre, it's unlikely that they would have been chosen to present.

2. Samumed would only want to showcase their results in this high profile manner if they were impressive. If it was a purely academic study - physicians would want to present the results regardless if they were positive or negative because it's good for science and good for their CVs. But Samumed's goals are different - they're a company and they want to make money. If their results sucked, they wouldn't want them to be in the spotlight. Their presenting in this manner really suggests that they have something.

3. Their presenting at the "late breaking" session explains their silence after their initial preliminary announcement. When presenting at a late breaking session, there is an embargo placed on the data. Researchers/industry are forbidden to release their data prior to their presentation. This is to ensure that the actual conference maximizes its publicity (ie. if the results were released before, no one would go - this way, everyone is going to tune into the AAD conference to hear the results). In order to be able to present at the "late breaking" session, they likely had to submit their results back in December - so again, suggests that they haven't been wasting any time.

Don't worry about their presentation being short - that's standard for these kinds of things. Everyone is allotted the same amount of time to announce their results.

Honestly - I am really excited about this. They've already said their results were sufficient to move to Phase 3 - and now they are presenting them at a late breaking session at the AAD. The AAD is a huge conference - much bigger than the Hair Congress. Note how this markedly contrasts from the way Allergan handled Bimatoprost - literally night and day. It's still just speculation - and we may all be disappointed - but I really believe there is a chance that Samumed may have what we've all been waiting for after all of these years. If they can stimulate stem cells to generate new follicles - and we already know that all of the stem cells are still there - they are just dormant - it seems like SM04554 may have the potential to provide full regrowth. Maybe the answer all along was increasing nuclear levels of beta-catenin to a necessary critical level. Here's to hoping...
 

nameless

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Nameless - I think this is extremely positive. Like you, I started to get worried after we never heard anything further from Samumed following their original preliminary announcement in early December indicating that the results from Phase 2 were positive. If they weren't showing pictures, then maybe their statistical benefit wasn't really reflective of a substantial clinical benefit...

But their presenting at the "late breaking research" session at the American Academy of Dermatology changes everything.

Why?

1. Getting to present research at a "late breaking" session is very competitive. There are usually a very large number of submissions (it's the entire dermatology community from around the world that is submitting) and only a select few are chosen for presentation. The conference wants to showcase its most exciting findings at the "late breaking" sessions - there will be lots of press. If the results were mediocre, it's unlikely that they would have been chosen to present.

2. Samumed would only want to showcase their results in this high profile manner if they were impressive. If it was a purely academic study - physicians would want to present the results regardless if they were positive or negative because it's good for science and good for their CVs. But Samumed's goals are different - they're a company and they want to make money. If their results sucked, they wouldn't want them to be in the spotlight. Their presenting in this manner really suggests that they have something.

3. Their presenting at the "late breaking" session explains their silence after their initial preliminary announcement. When presenting at a late breaking session, there is an embargo placed on the data. Researchers/industry are forbidden to release their data prior to their presentation. This is to ensure that the actual conference maximizes its publicity (ie. if the results were released before, no one would go - this way, everyone is going to tune into the AAD conference to hear the results). In order to be able to present at the "late breaking" session, they likely had to submit their results back in December - so again, suggests that they haven't been wasting any time.

Don't worry about their presentation being short - that's standard for these kinds of things. Everyone is allotted the same amount of time to announce their results.

Honestly - I am really excited about this. They've already said their results were sufficient to move to Phase 3 - and now they are presenting them at a late breaking session at the AAD. The AAD is a huge conference - much bigger than the Hair Congress. Note how this markedly contrasts from the way Allergan handled Bimatoprost - literally night and day. It's still just speculation - and we may all be disappointed - but I really believe there is a chance that Samumed may have what we've all been waiting for after all of these years. If they can stimulate stem cells to generate new follicles - and we already know that all of the stem cells are still there - they are just dormant - it seems like SM04554 may have the potential to provide full regrowth. Maybe the answer all along was increasing nuclear levels of beta-catenin to a necessary critical level. Here's to hoping...


And what about the fact that Samumed is presenting first? If the conference management team made the decision to put Samumed first, without Samumed paying extra for that privilege, then doesn't that suggest that the conference management team has decided that Samumed has the most important news to report? Maybe I'm reaching...I don't know. Or like I said, maybe Samumed paid extra to get to present first. Or maybe they just all drew straws for who would go first. I don't know. But if the conference management team made that selection intentionally, without any extra payment from Samumed, I do think that *might* mean that the conference committee felt that Samumed has the most important news.
 

xyz123

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And what about the fact that Samumed is presenting first? If the conference management team made the decision to put Samumed first, without Samumed paying extra for the privilege, then doesn't that suggest that the conference management team has decided that Samumed has the most important news to report? Maybe I'm reaching I don't know. Or like I said, maybe Samumed paid extra to get to present first. Or maybe they just all drew straws for who would go first. I don't know. But if the conference management team did select Samumed to go first, without any extra payment from Samumed, I do think that *might* mean that the conference committee felt
that Samumed has the most important news.

Agree. You can't pay at these conferences to go first - they are academic programs that are supposed to be, first and foremost, concerned with science and clinical relevance. That Samumed is scheduled to go first likely means that the selection committee felt that they had the most compelling findings. Again - speculation - but things are looking really positive.
 

nameless

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I have only seen 2 negative things about Samumed. One was the long delay in giving out new information and you have cleared that issue up so it is NOT a negative sign after all. The only other negative issue is that they termed their preliminary results from their original phase 2 "significant" and that is the term used for minoxidil the level of improvement. "Significant" improvement is not much in hair loss parlance. However, this company is new to hair loss research and they may not be using the word "significant" to delineate the same level of improvement that other hair loss companies do. Also, those were preliminary results so maybe they only used the term "significant" because they could see there was some regrowth but they were unsure how much at that time. So maybe they just used the term "significant" so they could publicize that there was some improvement without being specific while they waited for final results. Anyway, this is THE last and ONLY negative thing I've seen connected to SM04554 - the company's use of the word "significant" to delineate preliminary improvement data back in November. Other than this one issue all of the signs that I'm seeing are positive.
 

firstpost

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I have only seen 2 negative things about Samumed. One was the long delay in giving out new information and you have cleared that issue up so it is NOT a negative sign after all. There is also the issue that they termed their preliminary results from their original phase 2 "significant" and that is what has been said of drugs like minoxidil. Significant improvement is not much in hair loss parlance. However, this company is new to hair loss research and they may no be using the word "significant" to delineate the same level of improvement that other hair loss companies do. Also, those were preliminary results so maybe they only used the term "significant" because they could see there was some regrowth but they were unsure how much at that time. So maybe they just used the term "significant" so they could publicize that there was some improvement without being specific about how much improvement since they didn't have the complete data yet. Anyway, this is THE last and ONLY negative thing I've seen connected to SM04554 - the company's use of the word "significant" to delineate preliminary improvement data back in November. Other than this one issue all of the signs that I'm seeing are positive.

I'm very confident that SM04554 works, but because of that word "significant" I'm not sure yet how much.

I guess it depends what your Norwood is. If you are like NW2-3, significant might just be enough to get you to NW0-1.
 

NewUser

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It doesn't look like they're going to talk very long.

- - - Updated - - -

Their supplemental phase 2 study is still active. *If* they have the final results of the original phase
2 study, and if those results are bad, wouldn't they shut down their supplemental phase 2 study?

https://www.clinicaltrials.gov/ct2/show/NCT02503137

I agree, I can't see much point in testing a solution that has already failed at whatever dose. I think it would be back to the drawing board in that case not let's spend even more money on clinical trials, cross our fingers one more time and hope for the best? There must be a pretty good reason for this supplemental trial. I'm guessing they have positive results from phase 2A and are now looking for optimal lowest dose to satisfy a less is safer principle. Not sure but I think they should have tested low, middle and high doses already? Could it be that they need to find out at what lower dose it stops working?
 

nameless

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Why wouldn't they put the most compelling presentation last, just as a headliner band performs last? That's the way it's done at most conferences with featured/highly anticipated speakers. I still have high hopes, but just curious.

You're comparing apples and oranges. This is not a rock band. This is academia. I understand that in rock performances they save the best for last but I think that in academia they *might* put the top-scorer first. For example, when you were in school and the teacher put the grading curve on the blackboard did he/she put the highest scores at the top or the bottom of the list on the chalkboard? In my classes the top scores were always put on the chalkboard first. And "top-scorer" is the appropriate term to use in this situation because the submissions were scored as you will see deeper into this post. Keep in mind that the entire conference is like 4 days and Samumed is presenting in just one segment (that's only 2 hours long) of the entire conference. And the one segment where Samumed is presenting is for the "the latest ground-breaking" research and the AAD scored the information. Check out this quote from the ADD's announcement (bolding, underlining, and enlarging by me):

"Description:
These forums will highlight the latest ground-breaking observations in clinical, therapeutics, surgical, pediatric, dermatopathologic and basic research. Researchers are invited to submit abstracts describing their most recent results and the top scoring studies will be invited to discuss their findings in a brief oral presentation during one of the themed Forums."

Here again is the announcement:

https://www.aad.org/scientificsessions/am2016/SessionDetails.aspx?id=9717

Man, this is very exciting.
 

nameless

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the dream is to have something that causes regrowth that can be maintained with anti androgens


But isn't it possible that SM04554 could stimulate the Wnt pathway in such a way that it stays stimulated for a long time even after you cease to use the product?
 

Folliman

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But isn't it possible that SM04554 could stimulate the Wnt pathway in such a way that it stays stimulated for a long time even after you cease to use the product?

That's possible too, I'm just trying to be more realistic. I'd be more than happy if it's something that causes as much regrowth as minoxidil but you only have to apply it once a week (instead of x14/week). That would be ground-breaking and a huge step forward.
 

nameless

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LOL, this is why I said "that's the way it's done at most conferences..." - I've published and presented papers/posters but they weren't medical, and they still save the best for last. I don't think it lessens Samumed's potential impact since people don't seem to care about baldness anyway. Just saying...and looking at the other titles, I don't see what could be that impactful.


I just spoke with the AAD and I was informed that there are 4 different sessions of the "late breaking" category and each session has multiple (12) presentations. She also said the presentations are scheduled in no
particular order. She emphatically stated that the degree of importance or score were not considered in how they were placed in the session. She said scoring was only a factor in whether or not they got to present
at all. She said each presenters placement for presentation is random. So in this case the best is NOT saved for last.
 

Blackber

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I think everyone just needs to relax and wait until the news is announced.

"It is what it is"

We all want there to be spectacular news but trying to jump to conclusions based on what order the presentation is given is a little much. As nameless has stated their research was enough to convince AAD they deserved a spot that should be enough to make us all feel a little more optimistic than we usually do. Let's just wait and see what happens next week.
 

buckthorn

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I think everyone just needs to relax and wait until the news is announced.

"It is what it is"

We all want there to be spectacular news but trying to jump to conclusions based on what order the presentation is given is a little much. As nameless has stated their research was enough to convince AAD they deserved a spot that should be enough to make us all feel a little more optimistic than we usually do. Let's just wait and see what happens next week.

exactly - I also think we should be researching how to get their exact product synthesized ourselves, some how some way.. y'all are smart as hell and have resources... I don't know too much about SM04554, but can we have it made ourselves?
 

I.D WALKER

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Here's me affecting positivity:
Let's count only business days from here on out.
And now we are left with just about 6 more days to go..,
Yeah that looks better.
 
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