Sm04554

[nameless]

Tell yourself whatever you need to to make this really bad news sound better.

Dude, this may be bad news but none of us knows yet. You're guessing.

[dus]

Tell yourself whatever you need to to make this really bad news sound better.

Tell yourself whatever you need to to make this non-news sound bad.

[Tenma]

They are extending their complementary phase II. The big one finished on november and Samumed principal investigator said the results where very promising.

Yazici also said the company will present results on upcoming medical conferences, so we'll have to wait a little more to know how effective this stuff really is

Some people are just too negative without any good reason

[20legend]

After going through the trial changes made on Jan 12 for SM, I think the important part is they want to study the changes taking place 45 days after stopping the treatment, key being stopping treatment.

My guess would be they saw something during the initial 90 days and now want to see if those changes last after the application is stopped or not. Something similar to Minox where the effect diminishes after you stop using it.
Also note they will be monitoring B-catenin levels Ki expressions after 45 days. So if the effect diminishes maybe they will determine it from those levels.

Again all this is assumptions. We have had severe bad luck in the past.

[nameless]

I just figured something out guys.

The US Senate originally intended to do the 21st Century Cures Act in January 2016 and Samumed originally intended to conclude its' supplemental phase 2 study in January 2016.

The Senate delayed the 21st Century Cures until Spring 2016 and Samumed also extended their supplemental phase 2 study until Spring 2016.

Interesting. I think this looks like a VERY positive sign. It looks like Samumed decided to extend their supplemental phase 2 study so they could gather more biological information (since the 21st Century Cures has been delayed anyway) in the hope that they can take advantage of the Acts provision to allow drug companies to use biologic data in lieu of a phase 3 study. It looks like Samumed recognized that the cures Act would be delayed a few months so they decided to use those few months to gather more biological information. If I'm right that means Samumed is hoping to skip phase 3 and it also means that they think their drug is better than what is currently on the market.

It looks very conspicuous that Samumed's original completion date for the supplemental phase 2 happened to coincide with when the Cures Act was originally intended to pass and Samumed's extension of their supplemental phase 2 study happens to also coincide the intended time frame when the Cures Act will pass.

[doinmyheadin]

I just figured something out guys.

The US Senate originally intended to do the 21st Century Cures Act in January 2016 and Samumed originally intended to conclude its' supplemental phase 2 study in January 2016.

The Senate delayed the 21st Century Cures until Spring 2016 and Samumed also extended their supplemental phase 2 study until Spring 2016.

Interesting. I think this looks like a VERY positive sign. It looks like Samumed decided to extend their supplemental phase 2 study so they could gather more biological information (since the 21st Century Cures has been delayed anyway) in the hope that they can take advantage of the Acts provision to allow drug companies to use biologic data in lieu of a phase 3 study. It looks like Samumed recognized that the cures Act would be delayed a few months so they decided to use those few months to gather more biological information. If I'm right that means Samumed is hoping to skip phase 3 and it also means that they think their drug is better than what is currently on the market.

It looks very conspicuous that Samumed's original completion date for the supplemental phase 2 happened to coincide with when the Cures Act was originally intended to pass and Samumed's extension of their supplemental phase 2 study happens to also coincide the intended time frame when the Cures Act will pass.

Thats very cryptic..

[Hemo]

I don't think the delay is necessarily bad, but your theory doesn't make much sense. If the Cures act was supposed to be voted on in Jan, why would they want to end their trial at the same time? It would make more sense to end their trial prior to the vote so they could have data/analyses/evidence on hand to submit as soon as possible.

I also think you mean suspicious and not conspicuous.

[nameless]

I don't think the delay is necessarily bad, but your theory doesn't make much sense. If the Cures act was supposed to be voted on in Jan, why would they want to end their trial at the same time? It would make more sense to end their trial prior to the vote so they could have data/analyses/evidence on hand to submit as soon as possible.

I also think you mean suspicious and not conspicuous.

1. I meant conspicuous. Conspicuous means something is clear visible...stands out

2. What do you mean my theory doesn't make sense? Why would it make more sense to end their trial prior to the vote? How can you be sure of that? We don't know all of the ins and outs and fine details of gathering clinical trial data and submissions to the FDA. I disagree with you. I think it's conspicuous (clear) that Samumed is making the development of SM04554 mirror the track of the "Cures Act". The small and large details of how far before or after passage of the Cures Act would be the optimum date to have SM04554 complete the extended phase 2 trials is something none of us would know. We don't know all of the details of what Samumed would have to do in order to best take advantage of the passage of the Cures Act insofar as their product SM04554 goes.

[nameless]

Nope. Not cryptic at all. It's a positive sign.

Thats very cryptic..

I just figured something out guys.

The US Senate originally intended to do the 21st Century Cures Act in January 2016 and Samumed originally intended to conclude its' supplemental phase 2 study in January 2016.

The Senate delayed the 21st Century Cures until Spring 2016 and Samumed also extended their supplemental phase 2 study until Spring 2016.

Interesting. I think this looks like a VERY positive sign. It looks like Samumed decided to extend their supplemental phase 2 study so they could gather more biological information (since the 21st Century Cures has been delayed anyway) in the hope that they can take advantage of the Acts provision to allow drug companies to use biologic data in lieu of a phase 3 study. It looks like Samumed recognized that the cures Act would be delayed a few months so they decided to use those few months to gather more biological information. If I'm right that means Samumed is hoping to skip phase 3 and it also means that they think their drug is better than what is currently on the market.

It looks very conspicuous that Samumed's original completion date for the supplemental phase 2 happened to coincide with when the Cures Act was originally intended to pass and Samumed's extension of their supplemental phase 2 study happens to also coincide the intended time frame when the Cures Act will pass.

[Tomtom21]

I think everyone needs to shut up about the cures act and skipping phase III. I think we can say with near certainty samumed will need to conduct a phase III. In light of that I think the extension is neither good nor bad. I believe it is samumed covering their asses due to the fact that messing with wnt pathways can potentiate cancer development and risks. Thus by taking biopsys and checking biomarkers they may better establish safety of their product. Like other products mentioned on *** regarding curis.. Product 100% worked for hairgrowth but also caused/increased risk of cancer. I truly believe samumeds gonna be big how big im not sure but for them to even come out in their last media release claiming hair follicle generation speaks for itself. I think again this is more about ensuring the product can get to market as fast as possible without hitting red tape issues later on about carcinogenicity issues

[nameless]

I don't think the delay is necessarily bad, but your theory doesn't make much sense. If the Cures act was supposed to be voted on in Jan, why would they want to end their trial at the same time? It would make more sense to end their trial prior to the vote so they could have data/analyses/evidence on hand to submit as soon as possible.

I also think you mean suspicious and not conspicuous.

Also, I think that after these congressional acts are completed they go to the president for signature and then they become law after some small amount of time like 30 days or 90 days or something like that. This is what I mean by we do not know all of the ins and outs and fine details for when is the optimum time for Samumed to complete their supplemental trial; the only thing we can see for certain is that Samumed's track for completing their supplemental phase 2 trial is running parallel to the completion of the Cures Act even when the timeline of the Cure's Act changes.

[nameless]

I think everyone needs to shut up about the cures act and skipping phase III. I think we can say with near certainty samumed will need to conduct a phase III. In light of that I think the extension is neither good nor bad. I believe it is samumed covering their asses due to the fact that messing with wnt pathways can potentiate cancer development and risks. Thus by taking biopsys and checking biomarkers they may better establish safety of their product. Like other products mentioned on *** regarding curis.. Product 100% worked for hairgrowth but also caused/increased risk of cancer. I truly believe samumeds gonna be big how big im not sure but for them to even come out in their last media release claiming hair follicle generation speaks for itself. I think again this is more about ensuring the product can get to market as fast as possible without hitting red tape issues later on about carcinogenicity issues

I think you need to shut up with telling other people to shut up. I also think it's OBVIOUS that Samumed is intentionally mirroring the Cures Act. It's obvious because they initially planned to complete their supplemental phase 2 about the same time the Cures Act would pass. Then the government changed the date the Cures Act would pass and Samumed changed the date their phase 2 would complete and they again set the completion date to mirror the Cures Act completion.

It's clear that Samumed intends to try to activate the provision in the cures act that allows them to skip the phase 3. If the cures act passes with the provision that would allow drug companies to skip the phase 3 then Samumed will skip the phase 3. That is their obvious intention.

[Tomtom21]

@nameless... same team bud. I like you just want to see something come to market for improvement this hair loss condition sucks and can be an emotional/psychologic terror. For one, I said to chill with Cures Act because this beautiful country's legislation making process could allow the senate to completely butt rape the intended Cures Act so that it looks nothing like its original provision, or they can attach all junk provisions to the ends of it so that it fails to be passed through, or just completely take action on it to get it approved. I think caution must be used when discussing the implementation of legislation that has yet to pass senate. Also, while Samumed has changed its time line in what may seem like in accordance with the changes in Cures Act timeline, it is hard to say they intend to skip phase III. Most companies operate on a pray for the best (cures act passes and skip phase III) , but expect the worst (Cures Act is botched and Phase III is required). Either way we both have our own opinions on the matter all I am saying is I believe that pending an improved safety profile data from the biomarkers, this could be good news in expediting approval either way with or without cures act because we wont have to worry about FDA claiming its carcinogenic. Same team brother hopefully we hear something soon, Id love to know if anybody has heard anything regarding when Samumed might make their next appearance and announce some data.

[nameless]

@nameless... same team bud. I like you just want to see something come to market for improvement this hair loss condition sucks and can be an emotional/psychologic terror. For one, I said to chill with Cures Act because this beautiful country's legislation making process could allow the senate to completely butt rape the intended Cures Act so that it looks nothing like its original provision, or they can attach all junk provisions to the ends of it so that it fails to be passed through, or just completely take action on it to get it approved. I think caution must be used when discussing the implementation of legislation that has yet to pass senate. Also, while Samumed has changed its time line in what may seem like in accordance with the changes in Cures Act timeline, it is hard to say they intend to skip phase III. Most companies operate on a pray for the best (cures act passes and skip phase III) , but expect the worst (Cures Act is botched and Phase III is required). Either way we both have our own opinions on the matter all I am saying is I believe that pending an improved safety profile data from the biomarkers, this could be good news in expediting approval either way with or without cures act because we wont have to worry about FDA claiming its carcinogenic. Same team brother hopefully we hear something soon, Id love to know if anybody has heard anything regarding when Samumed might make their next appearance and announce some data.

Sorry for getting after you. I took it a little personal the way you said, "Shut up" but now I know you didn't really mean it the way it sounded. I see now that you are a much more reasonable person. That having been said, we are going to have to disagree because while I agree with you that the act could change radically in respect to the provision I'm referring to about skipping phase 3, I do not think it's going to. My reasons for that are (1) the USA has to compete with other countries and the USA knows that Japan has passed legislation that allows for reducing the time for clinical trials, including eliminating phase 3 in some cases and (2) I think pharma (including Samumed) has people in the know who have a good idea how the senators are planning to vote on that specific provision and I think the way Samumed mirrored Congress's original anticipated passage date (for the Cures Act) and then later when Congress changed that date Samumed changed their date to again mirror Congress's NEW anticipated date of passage looks too designed to be coincidental. I definitely believe that Samumed changed the completion date of their supplemental phase 2 to coincide with when Congress will pass the Cures Act. I think that when Congress extended the date to approve the Cures Act Samumed decided to extend the date of their supplemental phase 2 because they figured they might as well keep gathering more biological information since Congress delayed the Cures Act passage anyway.

[Hemo]

I emailed them yesterday to see if they had a target conference/timing for when initial phase II results would be released - doubt I'll get an answer, but maybe they'll put something out if a lot of people email?

They seem to have a pretty low profile - not much of an online presence other than a facebook with no posts and a website, which is pretty light on details.