Sm04554

[BoSox]

This would be amazing if it could bridge me(us) to Replicel. Praying for good results.

[Hemo]

This would be amazing if it could bridge me(us) to Replicel. Praying for good results.

This probably won't be available for another 3 years if it goes into production - they still have to plan and run their phase III trial and handle everything that goes into production. If we're lucky, Replicel will be available in Mexico sooner than this.
However, I also have high hopes for this - can't wait to see the initial phase II results.

[Trouse5858]

If the 21st century Cure Act were to nullify the need for a phase III what would be an optimist timeline for this??

[doinmyheadin]

This probably won't be available for another 3 years if it goes into production - they still have to plan and run their phase III trial and handle everything that goes into production. If we're lucky, Replicel will be available in Mexico sooner than this.
However, I also have high hopes for this - can't wait to see the initial phase II results.

I think your refering to Histogen regarding Mexico release. Replicel is now experiencing more delays in the German trial and may not start to the end of this year! No news on whether Shiseido will begin as yet. Replicel are yet to post any cosmetic results. I peraonally dont have much faith in them. Hopefully im wrong, fingers crossed for Histogen with no more delays.

[Occulus]

If the 21st century Cure Act were to nullify the need for a phase III what would be an optimist timeline for this??

You - and many others on this board - fundamentally don't understand what that bill's about. It doesn't get rid of phase III trials, it allows drugs that haven't completed phase III trials to be given to patients in DIRE NEED. Cosmetic applications will not be considered "dire need" situations. That act will have absolutely NO IMPACT on drugs trailing for hair loss. None. It will apply to those conditions that are TERMINAL ONLY.

[Hemo]

If the 21st century Cure Act were to nullify the need for a phase III what would be an optimist timeline for this??

I guess that depends when the Cure Act goes to a vote - we're in Jan, and it might not get approved until December for all we know. Even so, I think people are getting really optimistic about that eliminating phase III for all AGA treatments. My understanding is that its focus is to expedite approval of cell based treatments (eg stem cell treatments), which would only affect a few new procedures. I'm not sure this will qualify, but happy to hear other points of view.

[ShookOnes]

You - and many others on this board - fundamentally don't understand what that bill's about. It doesn't get rid of phase III trials, it allows drugs that haven't completed phase III trials to be given to patients in DIRE NEED. Cosmetic applications will not be considered "dire need" situations. That act will have absolutely NO IMPACT on drugs trailing for hair loss. None. It will apply to those conditions that are TERMINAL ONLY.

You couldn't be more wrong lol. Why don't you do actual research on the type of therapies it involves? Hint: starts with cell.

[champpy]

I believe somewhere it was reported that samumed would be releasing more info at the next conference they attended. I tried to google search to see if they were scheduled at any upcoming events but couldnt find any. Anyway, hopefully soon they will give us a tidbit on further developments

[xyz123]

When has that ever been the case? When is it ever "good news" that a study has to be extended? Never.

Looks like we can take SM off the list.

Wow... Great statement - studies in medicine get extended ALL OF THE TIME when a positive result is seen - they want to observe 1) Is the result sustained? 2) Do the results get better over time? When do studies not get extended? - when the initial results are an abject failure.

We already know SM works - they've said in a press release they've seen enough to move on to Phase 3 trials. The question is how well.

They've just gotten WAY MORE ambitious with their endpoints in this study - when the trial was initially posted there were a couple of primary and secondary endpoints. Now there are LONG lists for each. If a drug is failing, companies don't suddenly invest more money into a failing drug - and they don't suddenly expand the number of endpoints to be examined to highlight how bad the drug is. Samumed has drugs in development in 10 other areas of medicine - if the drug was failing, they wouldn't be wasting more money in this area. They would be quietly moving on.

SM works - and - although we can't be certain - I think it's hugely positive that they've added an endpoint 45 days after treatment has stopped. As another poster said - this HIGHLY suggests that they've seen something from their original Phase 2 study to make them believe that the result is sustained or even gets better.

I can't wait for them to present their Phase 2 results.

[Occulus]

Wow... Great statement - studies in medicine get extended ALL OF THE TIME when a positive result is seen - they want to observe 1) Is the result sustained? 2) Do the results get better over time? When do studies not get extended? - when the initial results are an abject failure.

We already know SM works - they've said in a press release they've seen enough to move on to Phase 3 trials. The question is how well.

They've just gotten WAY MORE ambitious with their endpoints in this study - when the trial was initially posted there were a couple of primary and secondary endpoints. Now there are LONG lists for each. If a drug is failing, companies don't suddenly invest more money into a failing drug - and they don't suddenly expand the number of endpoints to be examined to highlight how bad the drug is. Samumed has drugs in development in 10 other areas of medicine - if the drug was failing, they wouldn't be wasting more money in this area. They would be quietly moving on.

SM works - and - although we can't be certain - I think it's hugely positive that they've added an endpoint 45 days after treatment has stopped. As another poster said - this HIGHLY suggests that they've seen something from their original Phase 2 study to make them believe that the result is sustained or even gets better.

I can't wait for them to present their Phase 2 results.

Great - give me some examples of a product that made it to market after the Phase IIs were extended. I can give you some that didn't, particularly hair growth protocols, to wit: bimotoprost, dutasteride, etc.

[BoSox]

Wow... Great statement - studies in medicine get extended ALL OF THE TIME when a positive result is seen - they want to observe 1) Is the result sustained? 2) Do the results get better over time? When do studies not get extended? - when the initial results are an abject failure.

We already know SM works - they've said in a press release they've seen enough to move on to Phase 3 trials. The question is how well.

They've just gotten WAY MORE ambitious with their endpoints in this study - when the trial was initially posted there were a couple of primary and secondary endpoints. Now there are LONG lists for each. If a drug is failing, companies don't suddenly invest more money into a failing drug - and they don't suddenly expand the number of endpoints to be examined to highlight how bad the drug is. Samumed has drugs in development in 10 other areas of medicine - if the drug was failing, they wouldn't be wasting more money in this area. They would be quietly moving on.

SM works - and - although we can't be certain - I think it's hugely positive that they've added an endpoint 45 days after treatment has stopped. As another poster said - this HIGHLY suggests that they've seen something from their original Phase 2 study to make them believe that the result is sustained or even gets better.

I can't wait for them to present their Phase 2 results.

Thanks for clarifying that up! When exactly will they presenting those results?

[bigentries]

If a drug is failing, companies don't suddenly invest more money into a failing drug - and they don't suddenly expand the number of endpoints to be examined to highlight how bad the drug is. Samumed has drugs in development in 10 other areas of medicine - if the drug was failing, they wouldn't be wasting more money in this area. They would be quietly moving on.

This has happened before. Aderans expanded their phase two studies drastically with all the JiGami timelines that went absolutely nowhere

[dus]

This has happened before. Aderans expanded their phase two studies drastically with all the JiGami timelines that went absolutely nowhere

Treatment methods aren't really comparable. This is just a drug.

[Occulus]

Treatment methods aren't really comparable. This is just a drug.

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

[nameless]

You - and many others on this board - fundamentally don't understand what that bill's about. It doesn't get rid of phase III trials, it allows drugs that haven't completed phase III trials to be given to patients in DIRE NEED. Cosmetic applications will not be considered "dire need" situations. That act will have absolutely NO IMPACT on drugs trailing for hair loss. None. It will apply to those conditions that are TERMINAL ONLY.

You're dead wrong. The cures act passed by the house would allow virtually ALL drugs to use biomarkers in place of a phase 3 study. ALL.