Where are the phase IIb results for Bimatoprost?

[rdawg]

I too would give it a try, even if the effects were no better than minox.

I do think their "enhanced" version of Bim will included Setipiprant. Bad thing about that is it will be a loooong time before that is ready, and its not even proven that Set will be of benefit. So for all we know, after the next Phase 2 we will still be in the same position as we are today, with mediocre results and them back to the drawing board.

Its a damn shame though that this wont be produced because it would sell as an alternative to Minox. My guess is that right now its just to costly to produce on a large scale basis.

As for sides, could the sides be any worse than what we get from Minox, fin or dut? I find it hard to believe that they would be.

Since we now see that 1% bim does work to some degree, is it possible that we could get this from another supplier eventually or from the black market. We ha vethe concentration, I think we just need a good vehicle now so that we know it actually penetrates the scalp

I would think that would be extremely expensive, I recall people saying 0.1% was very costly, you'd have to be rich to afford 3%.(similar problem with CB being tested at a high dose but would be more than a HT to test on the grey market).

in regard to your first point, it seems clear they know the dose they need to aim for now and just need to perfect it(although it's annoying that this cant be tested out in a phase III, just adds an extra year) so there's nothing negative to be taken from here. Seti is promising as it's already been tested in a Phase I by over 1000 respondents, and can likely be fast tracked within 3-4 years.

I think the key to take from this is, BIM is coming out(and likely SETI as well), it's just finding the perfect dose. We're not in a 5 year range here anymore, more of a 2-3 year timeframe until we get at the very least an alternative to minox(and for many, this may work for people where minox didnt!).

[rdawg]

Only thing I'm confused on is this whole Subject self assesment vs. panel review vs. investigator global assesment.

what does that all mean exactly and how are they so different in their findings, as the latter two showed a 10-15% improvement over minox 5%

[champpy]

I wish they would have actually done a hair count difference, to see if any new hair actually grew. For all we know it might have just strenghtened his existing hair and not grown anything new

[It's2014ComeOnAlready]

I would think that would be extremely expensive, I recall people saying 0.1% was very costly, you'd have to be rich to afford 3%.(similar problem with CB being tested at a high dose but would be more than a HT to test on the grey market).

in regard to your first point, it seems clear they know the dose they need to aim for now and just need to perfect it(although it's annoying that this cant be tested out in a phase III, just adds an extra year) so there's nothing negative to be taken from here. Seti is promising as it's already been tested in a Phase I by over 1000 respondents, and can likely be fast tracked within 3-4 years.

I think the key to take from this is, BIM is coming out(and likely SETI as well), it's just finding the perfect dose. We're not in a 5 year range here anymore, more of a 2-3 year timeframe until we get at the very least an alternative to minox(and for many, this may work for people where minox didnt!).

These are all positive takeaways, and they are logical. Not over-speculation, not overly negative or positive. The truth is that we have a few treatments that are close, and hopefully the 21st Century Cures Act will help speed things up with all three. It's very likely it will, and Samumed at least has biomarker and surrogate endpoint data to support an alternative phase 3. Not to forget that Seti has conducted 8 clinical trials, with excellent safety data. Bim has also showed effectiveness AND safety in their trials.

imo it's a game of t-ball, fellas. It's sitting right there to be knocked out of the park. Great things for all of us will be here very soon. Hold on.

As far as the bill goes, the senator authoring the bill (Lamar Alexander) based on the one passed in congress, has previously published a few papers advocating for the FDA to speed up their trials and use biomarker and surrogate endpoint data. AND the new FDA chief, Dr. Robert Califf, installed by Obama has also written papers calling for the same.

[Hemo]

Eh, sounds to me like they're just putting it off until it can be tested/released alongside seti.

[cocacola]

Can someone illuminate me on phase 2b trial vs going into phase 3 and what could be the possible timelines to release in downside base and positive scenarios?

[rdawg]

Can someone illuminate me on phase 2b trial vs going into phase 3 and what could be the possible timelines to release in downside base and positive scenarios?

basically bumps it back a year, my guess is there are regulations where they cant just test a higher dose at phase III, they have to do a phase IIb all over again.

They've shown it works to an extent at 1% but 3% has shown to be even better.

timeline wise, if it went straight to phase III, we're talking Q1 2017 release, but since it's going back to phase IIb(and i find it near impossible they dont find what they are looking for this time) most likely a Q1-2 2018 release at best, Q4 2018-Q1 2019 at worst.

The positive news is they believe it works, I doubt a company would truly invest this much money and time into something they dont plan on pushing forward, they really want to maximize it's efficacy and possibly pair it with SETI. It's effective, it just needs to be perfected. Be happy we're talking 2-3 years at most!

[Hemo]

Can someone illuminate me on phase 2b trial vs going into phase 3 and what could be the possible timelines to release in downside base and positive scenarios?

I think it's a combination of dosage and delivery. It sounds like the "enhanced" version is more than just a higher dosage, so they likely have to test it before moving onto phase 3. I guess it's a good sign they're confident enough that the new formula will work/be better to put it through a trial.

[lacazette]

Regarding Bim, there's also the japanese equivalent developed by R-Tech Ueno

RK-023 (Nobiprostlan), an eyeleash drug tested for alopecia

In their pipeline from June 2015, RK-023 was about to enter phase2b and was 'open to license' ("RTU is aiming to make profit early by license or joint development")

http://rtechueno.com/en/company/busi...ness.html#rd09 (scroll to the middle for the pipeline)

so maybe it's another company now that continue the trials, or maybe they are in a joint development

[Paul73]

Hello guys,

Please, what´s your opinion on latanoprost? Do you think it could give similar results to Bim? I know we don´t have enough info about Bim., but many local pharmacies here in Brazil are already selling latanoprost. So at least the safety of the formula seems to be proven.

Should i give it a try? Let me know your thoughts. Thanks!