Sm04554

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  • Hemo
    replied
    They already have a phase IIb going, it ends in April (they're also looking at scalp biopsies in IIb, as opposed to the measurements they took in the first phase II).

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  • rdawg
    replied
    Alot of positives to take from this guys, I think people are jumping to conclusions way too fast here, I'll break down why:
    Here's the link to the official results release: https://www.samumed.com/files/2016/S...nal_3-1-16.pdf

    1. This was a 90 day once-a-day trial, then 45 days of post-treatment assesment, meaning they used the drug for a very short period of time. After stopping treatment, the hair count continued to increase at month 4-5 (histogen claimed the same thing and after a year had a significant increase)

    2. It shows clear efficacy on hair, and should really see how an increased dose affects the hair over the course of a year

    3. We're guarenteed at least a phase IIb here, and I would hope they do once a day for an entire year and see how it is, as well as follow up with the previous group post-treatment after a year and see if they maintained, increased or lost in hair count.

    4. The adverse events or side effects were very minor, mostly just tooth ache or muscle ache, nothing major as you can see in the slides above (and only about 5-10% of the subjects in the drug portion of the trial felt the affects).

    very very promising stuff, clearly on to something with this drug, I think the hope has to be that it continues to work as more time passes(which appears to be the case).

    hopefully they begin Phase IIb or Phase III right away.

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  • beetee
    replied


    Here's a link to the official posting of the results. There's a link within this to a slideshow.

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  • Dimoxynil
    replied
    Maybe theyre so confident that their product is decent that they chose to do a short 3 month trial so as to get in on the market more speedily.

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  • dm90
    replied
    Don't see why they would restart the phase 2 trial, I haven't read any official statements on that. The results show a steady, albeit slow, increase in hair and density even after discontinuation. That's pretty good news to me, I really believe they will go into phase 3 with this.

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  • beetee
    replied
    Originally posted by champpy
    No offense guys, but can we stay on topic here?

    Im so confused by what SM is trying to do. Their whole phase 2 was only 3 months? How is that possible when it seems they were extending it over and over?

    Do all researchers who are in a clinical trial have to present in such a public way? If this is less than stellar, why present this at a conference, couldnt they just have released the results online?

    And, why the hell would they be a sponser at the hair congress if they dont assume they can capitalize on it down the road? Where they counting their chickens before they hatched?

    So many of their moves sounded encouraging but to have to restart phase 2 again is a kick in the teeth, and it may yeild no better results than we see now.
    I don't know the answers to all of your questions, and some of them might not really have answers as different companies do different things even when they're seemingly in the same or very similar situations. That being said, I don't think companies have to release results at all and many that do only do so through back channel type methods, such as posting the results on the clinical trials government website or through investor conference calls. So, yes, I think in general companies release information at conferences when they think it's good news. However, they could try to spin half way decent results as being more positive than they are if they were trying to attract more publicity, although they only solicited Forbes for that one piece and most companies looking for money would have publicized the findings a lot more. It seems that a lot of hair loss product companies use some of those old studies of Rogaine and Propecia as the gold standard for how effective their products are (although both seem to more or less not work at all to me, so that may raise some general questions about the validity of medical trials, but that's a somewhat separate question). Are the results they reported significantly better than those old Rogaine and Propecia results? Also, where is the restarting Phase II stuff coming from, is that official or just people conjecturing/rumoring?

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  • dutchguyhanging
    replied
    Originally posted by allTheGoodNamesAreTaken
    That's enough thread hijacking for me, back to SM04554!!!
    results are published. they promise 10% in 3 months hahaha
    another charade .. yo all remember the pitch from fin right? yes it was around 40% close to 50%... so it probably makes 1% affect in reality which would not be cosmetically viable anyways.
    so what do you say guys? shall we ask admin to lock this thread...

    I now believe we have talked about SM even more than the scientists working for SM
    probably they werent even aware that so many people were waiting/talking otherwise they wouldnt have published such funny results

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  • allTheGoodNamesAreTaken
    replied
    That's enough thread hijacking for me, back to SM04554!!!

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  • champpy
    replied
    No offense guys, but can we stay on topic here?

    Im so confused by what SM is trying to do. Their whole phase 2 was only 3 months? How is that possible when it seems they were extending it over and over?

    Do all researchers who are in a clinical trial have to present in such a public way? If this is less than stellar, why present this at a conference, couldnt they just have released the results online?

    And, why the hell would they be a sponser at the hair congress if they dont assume they can capitalize on it down the road? Where they counting their chickens before they hatched?

    So many of their moves sounded encouraging but to have to restart phase 2 again is a kick in the teeth, and it may yeild no better results than we see now.

    Leave a comment:


  • Dimoxynil
    replied
    Originally posted by allTheGoodNamesAreTaken
    Yeah that's what I was thinking. I feel quite a bit more relieved after this realization. Actually it could also just be a back-up plan if a FUE on its own goes wrong. I would get the temporary 2 year tattoo though, **** gambling on a permanent one that could change colour after a while.
    Yes, temp SMP is a far more sensible option to me. I shave my bloody head anyway so it's not like it going to radically alter my look. Fred the Belgian and Spex know more than me about this stuff though.

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  • allTheGoodNamesAreTaken
    replied
    Originally posted by Dimoxynil
    The thing I like most about the concept is the low-risk element. If the FUE doesn't go so well (which it should do anyway) then you still have the SMP which should still look realistic enough if you use the right practicioner. If you use tricopigmentation then you have an exit strategy if the SMP doesn't give you what you want. So it's far from an all or nothing option. You almost have nothing to lose by going for it
    Yeah that's what I was thinking. I feel quite a bit more relieved after this realization. Actually it could also just be a back-up plan if a FUE on its own goes wrong. I would get the temporary 2 year tattoo though, **** gambling on a permanent one that could change colour after a while.

    Leave a comment:


  • Dimoxynil
    replied
    Originally posted by PatientlyWaiting
    I actually have interest in that, and I know what you are talking about, not the case, but the concept. I've been interested for the past year. Only thing is I wanna do the whole head including filling in the donor area to make it appear fuller, which would cost about $4,500 or so (for the whole head).
    The thing I like most about the concept is the low-risk element. If the FUE doesn't go so well (which it should do anyway) then you still have the SMP which should still look realistic enough if you use the right practicioner. If you use tricopigmentation then you have an exit strategy if the SMP doesn't give you what you want. So it's far from an all or nothing option. You almost have nothing to lose by going for it

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  • PatientlyWaiting
    replied
    Originally posted by Dimoxynil
    From what I've seen just browsing SMP forums, the results can look VERY good. Just having some real hair around the hairline can give a very realistic look. I saw one guy who used just 800 grafts to replicate a hair line and the rest was standard tricopigmentation. I'm quite amazed that there's no great interest in it on here.
    I actually have interest in that, and I know what you are talking about, not the case, but the concept. I've been interested for the past year. Only thing is I wanna do the whole head including filling in the donor area to make it appear fuller, which would cost about $4,500 or so (for the whole head).

    Leave a comment:


  • Dimoxynil
    replied
    Originally posted by rambo007
    Could you post a link to that case? I would be very grateful.
    Will try and find it

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  • allTheGoodNamesAreTaken
    replied
    Originally posted by Dimoxynil
    From what I've seen just browsing SMP forums, the results can look VERY good. Just having some real hair around the hairline can give a very realistic look. I saw one guy who used just 800 grafts to replicate a hair line and the rest was standard tricopigmentation. I'm quite amazed that there's no great interest in it on here.
    It actually sounds like a good solution the more I think about it. Officially my plan B now, since it's probably still possible even for people with weak donor region. Not as good as thick, flowing locks but vastly better than a half-bald head with no hairline.

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