Sm04554

[Trackster]

Just hope they show good results from their first phase 2 trial. That should hopefully be presented soon.

[TooMuchHairWontKillYou]

I see two reasons of expending this trial.

1) They didn't see expected results in this time and gave it more time
2) They saw some results and want to study it more.

[Hubris]

Samumed has extended follow-up of it's scalp biopsy study to 135 days for secondary endpoints.

https://clinicaltrials.gov/ct2/show/...sm04554&rank=1

Hopefully this means that they've seen good results - and are hoping they get even better with time.

Can't wait to hear the formal results of their Phase 2 study.

I have no medical or scientific background. Could someone please explain what the above implies? Does this mean that they are conducting another phase 2, or that they are extending the length of time that they are investigating the results of the phase 2? Alternatively, something else? Thanks.

[dus]

I have no medical or scientific background. Could someone please explain what the above implies? Does this mean that they are conducting another phase 2, or that they are extending the length of time that they are investigating the results of the phase 2? Alternatively, something else? Thanks.

Guess: they are extending the current trial by 45 days, so probably shit is still happening that they can monitor. If it was a dud, they wouldn't extend it.

[TooMuchHairWontKillYou]

I have no medical or scientific background. Could someone please explain what the above implies? Does this mean that they are conducting another phase 2, or that they are extending the length of time that they are investigating the results of the phase 2? Alternatively, something else? Thanks.

They have finished first phase 2 (October 2014 - November 2015)

and now they are expanding their second phase 2 (biopsy)

[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.