Sm04554

[baldybald]

Remember guys a lot of products failed in phase 3 and I hope this is not the one

[TooMuchHairWontKillYou]

Remember guys a lot of products failed in phase 3 and I hope this is not the one

Can you write briefly what is phase 3? and did hair loss products fail in phase 3 in the past?

[baldybald]

Can you write briefly what is phase 3? and did hair loss products fail in phase 3 in the past?

I really do not remember the source, but I saw it from a website and one member mentioned that the easiest phase is phase 1 and the most difficult one is phase 3

[Tenma]

I really do not remember the source, but I saw it from a website and one member mentioned that the easiest phase is phase 1 and the most difficult one is phase 3

The critical moment seems to be the transition from ph. 2 to ph. 3: 38%

phase 3 success rate for small molecules like SM 3: 61%

http://www.biotech-now.org/business-and-investments/inside-bio-ia/2010/11/clinical-trial-success-rates-recent-study-from-tufts

[xyz123]

Can you write briefly what is phase 3? and did hair loss products fail in phase 3 in the past?

Wikipedia summarizes nicely:

"Phase III[edit]
This phase is designed to assess the effectiveness of the new intervention and, thereby, its value in clinical practice.[1] The percentage of Phase II trials that proceed to Phase III, as of 2008, is 18%.[6] Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment. Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions. Phase III trials of chronic conditions or diseases often have a short follow-up period for evaluation, relative to the period of time the intervention might be used in practice.[1] This is sometimes called the "pre-marketing phase" because it actually measures consumer response to the drug."

[rdawg]

The findings are consistent with preclinical in vivo animal models, in which SM04554 has been shown to generate new hair follicles and increase hair count.

Looks like we're getting incredibly close to a new product hitting the market.

BIM, SM and Histogen all showing a high amount of efficacy in phase 2+ trials.

very exciting times! Hopefully SM goes straight to phase III now, very unlikely it fails as they've already proven safety and just need to show widespread efficacy.

On top of that, they seem very happy with this product, already talking about releasing results at the next conference(while BIM was more hush-hush when they didnt quite get amazing results).

[Tenma]

I think Bimatoprost is almost done.

If SM significantly outperforms Minox in trials, the chances of seeing another growth stim will diminish considerably.

I still hope CB comes to the market. A receptor antagonist is always welcome

[allTheGoodNamesAreTaken]

I think Bimatoprost is almost done.

If SM significantly outperforms Minox in trials, the chances of seeing another growth stim will diminish considerably.

I still hope CB comes to the market. A receptor antagonist is always welcome

Do SM and Bim work on different stages of whatever the chain of processes is that causes follicles to go bad though?

[champpy]

If that 21st century cures act passes couldnt they skip phase 3?
Also, shouldnt that act be getting the yay or nay anyday now?

[BiqqieSmalls]

Imagine if they had said 'dramatically significant', we would all be popping a cork right now

Sigh. Dramatically significant is not a "statistics" term.

[champpy]

If that 21st century cures act passes couldnt they skip phase 3?
Also, shouldnt that act be getting the yay or nay anyday now?

[doinmyheadin]

^^ Yes would love to know whats going on with the act

[deuce]

Does this retain hair as well?

[champpy]

Duece. We should know more hopefully in jan when phase 2 wraps up. If it retains hair thats a huuuuge plus

[ShookOnes]

U guys think it'll work on hairline?