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I feel like I'm very unbiased and his point is certainly valid. The new legislation is great but it's not going to make the treatments any more or less effective. And treatments in the 'pipeline' are the very definition of experimental and there's really no foreshadowing their efficacy on humans whether your're an optimist or a jaded cynic. I'm quite thankful that we have various teams working on the problem but at some point, results take precedence over talk. It's like when rival fans of horribly run football teams think they're going to win the Super Bowl before the start of every season. Half way through the year and they're already looking forward to next season. That's like the hair loss industry. "Just another year or two, baby. We got this."Comment
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I agree with his point to a small degree. But, it's not like a tremendous amount of research and discoveries haven't happened in the past 10 years (or more) that wouldn't lend themselves to new effective treatments. That quote, "just another year or two" btw was never really realistic up until now.
Between the number of drugs based on a lot of research and work, that are in phase 2 (or later), as well as the distinct possibility of a new bill being signed into law that will speed up and modernize clinical trials. The 21st Century Cures act, just got the majority of the House of Representatives of both dems and repubs, to cosponsor the bill before it goes to a vote. There is a strong belief it will be signed into law before the year is out. That means it could effect the speed in which we see bim, SM, and setipiprant, which will all be at phase 2 or higher.Comment
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Allergan's gonna have a second quarter earnings call on August 6th, there will also be a webcast. I wonder if they'll discuss the bimatoprost phase 2b results. Investor relations told biqqie smalls in May, they'd release the results in a "few months."
Joker pointed out that companies typically don't have press releases for failed drugs. Given the long, long silence regarding the trials, as well as the mutual reliance on prostaglandin science that seti and bim have, plus the fact that Allergan bough Kythera recently, and plans to develop seti....Also, what investor relations told a shareholder (biqqie smalls), I wonder if this could be it. Obviously, the entire press conference won't be about Bim alone, but I wonder if they'll touch on it.
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The senate will probably still be drafting and debating it by the time these drugs release in a few years. Nothing speeds up when congress touches it. Not to mention the years to actually implement any of the changes. Im not very optimistic about this bill speeding anything up anytime soon. I dont know anything in government that works quickly and if I got paid that kind of money to do that I wouldnt either.
I do think odds are some of the new treatments will work and get released this time. With the lack of info since money is involved its just whether your half glass full or half empty kind of person. There are quite a few things though and a good deal of sound science behind them so its hard not to be optimistic.Comment
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Please do more research with regard to the bill. They already have the majority of the house as cosponsors. They plan on getting more than 350 house votes (overwhelming majority) to send a strong message to the senate. They've said for months that they firmly believe this will be signed by the president before the year is out, and haven't changed their tune. It becomes law within 10 days once it's signed.
You are completely speculating.Comment
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As much as I hope allergan's buyout of Kythera suggests further interest in the PDG2/PGE2 theory, their last investor call seemed to demonstrate that Kybella is very much the reason for the buyout, and setipiprant is just an incidental add-on.
Kybella sits very well with Allergan's botox; could it just be a coincidence that seti and bim are now under the same roof?Comment
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Well, as it happens, the job of the CEO is to explain to shareholders and investors why they made the move on the drug that has already been proven in clinical trials. So, of course they cannot say "hey, look at the great job we did on getting a drug that hasn't yet proven efficacy." It would fall quite flat, so naturally, that's not the presentation they went with.
I'll also put this in perspective - you can get rid of a double chin by losing some weight. Most people aren't going to tell themselves, "I have a giant double chin, that's my only problem." No, the problem is you're overweight, and if you want to look better all around, you can lose some weight. You can't get your hair back if you start losing it without the help of meds.
Kybella being an injectable fits in well with the rest of what they have. No coincidence. If you want to properly treat hair loss, you will need a drug that will stop hair loss (seti), and a drug that will patch up thinning spots (bim). Luckily, bim will work anywhere on the scalp. Not a coincidence, either, because if this combo works as well, they control medical aesthetics for the entire head and face.
Many doctors have said PGE2 up, PGD2 down = hair. Not a coincidence.Comment
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It's an interesting combination for sure, I dont think seti was what they were after as you guys have stated but was part of the package that appealed to them doing the buyout.
this is good news though, Allergans is a big, powerful company and has alot of money to fund into this stuff and BIM and Seti are two very interesting and seemingly effective products.
at the very least we get results in early 2016, but I think there will be some kind of announcement with these two in the next few months here.
All in all, nothing ultra-positive, but we at least have some reason to be optimistic and 100% big news, good or bad will be coming to us very soon with CB, SM, BIM and SETI all moving to the next phase or finishing up their next phase within the next 6 months.Comment
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I came across an interview with David Pyott, and Jim Cramer from a few years ago, and they began talking about latisse etc. Pyott (former CEO of Allergan) said that before Latisse was even released, people were trying to get their hands on it. This would also be a problem for the mpb version.
Now, with regard to bim for the scalp - yes, in this instance, people would try and get their hands on it as well, and they could. Not only that, but as many of you know, Allergan has been in recent legal battles with companies who can make generic bim.
(I am completely speculating here, but I think I could be right in this instance)
So, to prevent people from buying this stuff themselves, or other companies/labs attempting to distribute bim at the right concentration, Allergan has kept completely quiet about the phase 2b trial. At the same time, they have quietly progressed with phase 3, and with the FDA's permission, have not posted a registered trial on clinicaltrials.gov.
I believe this is possible because they've already recruited participants from previous trials, and have the necessary amount for a phase 3 (meaning, there is no need to post as a recruitment tool). Also, this would prevent people from trying to get their hands on this drug before it came out, as well as the companies/labs who would seek to do the same. I believe this sort of arrangement could be made in this instance, in order to protect consumers from testing an unregulated chemical on themselves. I think given the FDA's stance on safety, this is a possibility. Allergan's experienced this sort of attempt with Latisse before it came out, and now that the drug is actually in the market, all the more likely and possible.
Every time, it seems when someone from a hair loss forum attempts to ask about the trial or drug, the person they speak with acts like they've never even heard of it. They're not guarding a failure. Allergan is too big of a company at this point to be afraid of a failed drug or trial.
Yes, the FDA sticks by the rules, but big pharma, and FDA work together. If a company producing a drug has very good reason (like the safety of others, and the protection of a company's ability to make money) to not post to the clinical trials website, I believe the FDA would certainly allow a small accommodation such as this.Comment
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lol 2014, I really love most of your posts. You keep the forum positive and are optimistic and I share your optimism that we will have better treatments in the future..but come on man, to suggest they already started phase III secretly is a little absurd.Comment
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I really wish that bim wasn't like minoxidil where you stop using and your hair just falls out lol. I don't know if this is old news or not, but I just saw my derm again two days ago and she is usually up on hair treatments and what not. She said that last she heard, there was a treatment (bim) that had good results, but the company was trying to get around the hyper pigmentation effects it had. It is known in the eye lash application, but I guess it was also affecting the scalp too.Comment
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Thank you, thank you lol. I'm not saying "secret," just not posted to clinicaltrials.gov for the reasons I have posted. I don't think it's that absurd. Is it really that much of a big deal not to post to a publicly accessible website? They don't need to recruit, and there is strong reason to believe their work will be stolen and/or used before it has had a chance to pass trials. There would be an incentive to omit posting in this case.
You really think the FDA would say no? They would be protecting consumers if they said yes.Comment
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2014, you're starting to sound like a conspiracy theorist. You can theorize all you want but none of it matters until results and/or a product is released. I'm as eager as everyone else here but we just have to sit back and wait.Comment
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