Where are the phase IIb results for Bimatoprost?

[BiqqieSmalls]

I've been an investor in an unrelated biotech for a year or so now, and I've learned the hard way that companies definitely aren't obligated to release trial result information to investors. It's very frustrating sometimes, but that's the way it is.

I am pretty sure these companies have a fiduciary duty to provide you with information that will aid in your financial decisions.

[Keki]

biqquie no news from yesterday?

[BiqqieSmalls]

biqquie no news from yesterday?

No news man

[BiqqieSmalls]

And it won't look like we'll get an answer soon.. But there is good news.

Research and Development head David Nicholson noted on the conference call earlier this week that Actavis had almost finished the rationalization of the companies' pipe lines and had decided to move forward with 70 projects. Some programs are still under review. I knew they wouldn't release results yet; this merger is so intricate. Also, keep in mind Bim was Allergan's product, not Actavis's...

When the Investor Relations told me 'a couple months', it sounds believable because Actavis will release Q2 earnings sometime in July.

[Keki]

Thx for the info, looked the q1 results aswell, they included Bimataprost SR Phase III recruiting US, Phase III initiation EU, 2015, no scalp phase 3 so i think it's a bad news... well at least for us, no info about the 25+ phase 3 projects...

If it's the same in q2 i don't think they will release any news, they will copy paste a similar presentation in q2 with no trial results, they don't even mentioned latisse in their earning... wtf, i miss the old allergan pipeline info, they now list only potential "milestone" and 0 info on secondary trials for their product

[rdawg]

So clearly the science backs up the product and it definitely has a positive result on hair!

this seems like the only product out there with a legit ability to grow or reinforce your hair! and it's so close to market release(nothing is done phase IIb!)

could it be side effect problems? patent issues? timing?

it will be really unfortunate if they come out and say the results were good but not good enough to release, would be really unhappy about that as the science really supports this drug!

[It's2014ComeOnAlready]

So clearly the science backs up the product and it definitely has a positive result on hair!

this seems like the only product out there with a legit ability to grow or reinforce your hair! and it's so close to market release(nothing is done phase IIb!)

could it be side effect problems? patent issues? timing?

it will be really unfortunate if they come out and say the results were good but not good enough to release, would be really unhappy about that as the science really supports this drug!

I caught some of Spencer's latest show, and Joe from SI called in. Bimatoprost was briefly mentioned, but Spencer made a very good point. He said that not releasing results may not have anything to do with good or bad, but only to do with business. There also may be a legal issue involved. My belief is, given that many other companies can legally manufacture bimatoprost, there may be a legal and business issue for them to release results prematurely, if it succeeded. There would also be a press-release, and likely news stories to follow. News would travel fast.

The investor relations person mentioned to BiqqieSmalls that the reason no results have been posted, is because of the "complexity of bimatoprost." That sounds like a legal, or business issue. I have a really hard time applying that same explanation to a failure. I'd say that explanation is quite simple - here are the results, they weren't sufficient enough for hair growth. No big deal, we're moving on with other successful products. No need to wait this long, no need for a press release, just results.

This is speculative, but I've always believed that Kythera's decision to move forward and start trials did have something to do with this drug succeeding. A phase 2b success would indicate the prostaglandin hypothesis having clinical proof of efficacy. Kythera's Chief Medical Officer worked at Allergan for 10 years, and could assuredly get information on that trial if they were planning on moving forward with something similar themselves. I'm sure he still has many ties to that company. After all, this is one of the first drugs being tested based on a "hypothesis." They must've needed many, many reasons to give them the will to move forward.

This drug does indeed work, but is it enough for them to produce? If it works, it would be amazing. It would be miracle grow for your hair, and unlike minox, it would work anywhere on the scalp. Unlike fin, it would actually regrow, and wouldn't have sexual side-effects.

rdawg, btw I included somewhere in the thread, the latest patent for bim that says the 3% range is perfect because it provides a surprisingly good balance between the wanted effects, without any unwanted side effects.

[Keki]

This doesn't explain why refuse to even mention bim scalp trial in every recent pdf, and we can forget a fast phase3 trial and the market release soon if they refuse to even release the results, if everything goes well for us they will release the trial results maybe at the end of the year, start another year trial, then wait for fda etc etc = at least early 2018, according to their february pdf aswell

[It's2014ComeOnAlready]

This doesn't explain why refuse to even mention bim scalp trial in every recent pdf, and we can forget a fast phase3 trial and the market release soon if they refuse to even release the results, if everything goes well for us they will release the trial results maybe at the end of the year, start another year trial, then wait for fda etc etc = at least early 2018, according to their february pdf aswell

It does explain it to a certain degree - there could be a legal and/or business issue holding them back from saying anything. Investor relations even said it was a complex issue why they haven't yet released results, and it has to do with the complexities surrounding the drug itself. How complex is it if the drug failed for hair loss? It works for other indications. That's not a big deal to say so, not all is lost because it works for other things like glaucoma and eyelashes.

Don't forget that phase 2b success = launch. Phase 3 is just a formality in this case.

[kantian]

What do you mean its just a formality? Isn't phase 3 necessary for fda approval? Can they start selling before phase 3?

[It's2014ComeOnAlready]

What do you mean its just a formality? Isn't phase 3 necessary for fda approval? Can they start selling before phase 3?

What I'm saying is that for this drug, if it made it through phase 2b (efficacy), it would almost certainly make it to market. They will do a phase 3 because they have to.

[jiggo]

Propably they are waiting for the end of the SM trial and depending on that they will decide to continue or not. SM could be a big thing I hope.

[It's2014ComeOnAlready]

Going to reiterate my reasoning to be positive about this drug, and I welcome someone to challenge my argument, using facts and logic.

Investor relations person says they haven't released phase 2b results, even to shareholders, because of the "complexity of bimatoprost." They've known the results of the trials for about 7 months, but haven't said a word to anyone, not even their beloved shareholders.

This is a strange case, but I side with optimism because we know the drug works. Also, several other companies can produce generic bimatoprost, so I'm beginning to believe it's a legal issue. In the past, what set Allergan's products containing bimatoprost apart were licensed trademarks (Lumigan, Latisse). I'm not certain things succeeded, but it may take being closer to having an actual product with an actual licensed trademark to release results, if it did in fact succeed.

Someone provide me a better argument why they haven't released results, even to shareholders, in 6+ months and I'll shut up. Convince me I'm wrong, I'm very open to it. Again, what's the harm in releasing the results of this one if it didn't work, when 70 other of their applications have worked, 50 of which are late stage?

[rdawg]

Going to reiterate my reasoning to be positive about this drug, and I welcome someone to challenge my argument, using facts and logic.

Investor relations person says they haven't released phase 2b results, even to shareholders, because of the "complexity of bimatoprost." They've known the results of the trials for about 7 months, but haven't said a word to anyone, not even their beloved shareholders.

This is a strange case, but I side with optimism because we know the drug works. Also, several other companies can produce generic bimatoprost, so I'm beginning to believe it's a legal issue. In the past, what set Allergan's products containing bimatoprost apart were licensed trademarks (Lumigan, Latisse). I'm not certain things succeeded, but it may take being closer to having an actual product with an actual licensed trademark to release results, if it did in fact succeed.

Someone provide me a better argument why they haven't released results, even to shareholders, in 6+ months and I'll shut up. Convince me I'm wrong, I'm very open to it. Again, what's the harm in releasing the results of this one if it didn't work, when 70 other of their applications have worked, 50 of which are late stage?

So how would the company protect the product then if it does work. That would be a very good reason to withhold results and stop competitors from selling the product as well.

do they have to file a patent? get it protected? What do they do so that they are the only ones to sell it?

[Joker]

Going to reiterate my reasoning to be positive about this drug, and I welcome someone to challenge my argument, using facts and logic.

Investor relations person says they haven't released phase 2b results, even to shareholders, because of the "complexity of bimatoprost." They've known the results of the trials for about 7 months, but haven't said a word to anyone, not even their beloved shareholders.

This is a strange case, but I side with optimism because we know the drug works. Also, several other companies can produce generic bimatoprost, so I'm beginning to believe it's a legal issue. In the past, what set Allergan's products containing bimatoprost apart were licensed trademarks (Lumigan, Latisse). I'm not certain things succeeded, but it may take being closer to having an actual product with an actual licensed trademark to release results, if it did in fact succeed.

Someone provide me a better argument why they haven't released results, even to shareholders, in 6+ months and I'll shut up. Convince me I'm wrong, I'm very open to it. Again, what's the harm in releasing the results of this one if it didn't work, when 70 other of their applications have worked, 50 of which are late stage?

So, here is a possible challenge to your argument:

1) Information about bimatoprost being "complex" is almost completely useless in context. The representative was clearly giving a vague, standard line to get an anxious shareholder off the phone. She wasn't giving secret hints about the progress of bimatoprost. There is nothing to see here.

2) If the product worked as planned, competition and patent concerns would only lead Actavis to accelerate the development of bimatoprost - not decelerate it.

3) Companies in the aesthetic space almost never release the results of failed products outside of traditional channels (clinicaltrials.gov, etc.). Doing so in this instance would be almost completely without precedent.

4) Shareholders are almost never made privy to detailed information related to the development of proprietary technologies. Being a shareholder is pretty easy. If shareholders were immediately given access to every piece of strategic information available, competitors would just buy shares in their competition to learn everything there is to know about the business strategies of their rivals. People speculating on this board have a very flawed understanding of fiduciary duties.

5) Taking all of the above together, we know absolutely nothing about the development of bimatoprost. The only thing we know is that almost no new hair loss products ever work - even the ones with good track records in preclinical trials (see: ICX, Aderans, Follica, Histogen, etc.). There is no reason to assume bimatoprost will be any different.