Where are the phase IIb results for Bimatoprost?

[macbeth81]

Someone provide me a better argument why they haven't released results, even to shareholders, in 6+ months and I'll shut up.

Because they don't always release results within months of trial completion. Just a quick sample of previous Allergan trials demonstrates this fact (below). The average from the sample provided is over 15 months. Now Allergan has completed many trials and this was just a sample, but enough to demonstrate they release results at their own leisure. I don't understand all the theories behind something that is not unusual.

Primary		Received	Months
Completion	Results		Apart	Identifier
--------------------------------------------------------
5/2012		5/21/2013	12  	NCT01391286
1/2011		6/24/2013	29  	NCT01189279
2/2014		1/27/2015	11	NCT01698554
5/2014		4/21/2015	11	NCT01830140
10/2011		8/13/2013	22	NCT01291108
4/2013		2/18/2014	10	NCT01646151
12/2013		1/16/2015	13	NCT01863953
11/2010		8/21/2012	21	NCT00907426
9/2010		12/13/2011	15	NCT01068964
7/2010		8/18/2011	13	NCT01064882

[FearTheLoss]

I thought they were required to release results in a year?

[macbeth81]

"Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) (PDF) requires Responsible Parties to register and submit summary results of clinical trials with ClinicalTrials.gov. The law applies to certain clinical trials of drugs (including biological products) and medical devices."

https://clinicaltrials.gov/ct2/about-site/results

From my sample above, with exception to three studies, the remaining seven were received at about a year. ClinicalTrials.gov is a government ran site, so I don't know how well this is enforced. What is required and what actually happens are sometimes two different things. For example, look how many people don't file their income tax return. Government doesn't track requirements very well and is generally inefficient.

[Keki]

If it worked why waste a year? It needs to pe public the eventual phase 3 anyway, so i don't understand, the complexity of bim and their patent issue are easily fixed by one of the top 5-6 pharma company

[Keki]

ok guys i found some info http://ec.europa.eu/competition/merg...4195749_EN.pdf

this document explain the "complexity", very interesting let me know what do you thing about this

[It's2014ComeOnAlready]

ok guys i found some info http://ec.europa.eu/competition/merg...4195749_EN.pdf

this document explain the "complexity", very interesting let me know what do you thing about this

Yea it definitely points to an issue with other companies being able to produce bimatoprost. No way to tell if the trial went well, but it does tell us that the issue with this drug is legally complex.

Just speculating, but if their explanation is that they haven't released results because of these "complexities," then it probably did well. Makes no sense to guard a failure, if overall, there is an issue where other companies can produce the drug themselves. If it didn't work for hair loss, I think we'd know by now. No money to be lost.

[FearTheLoss]

Has anyone got a definitive answer on when these results will, or have to be released? or are we still shooting in the dark?

[It's2014ComeOnAlready]

Has anyone got a definitive answer on when these results will, or have to be released? or are we still shooting in the dark?

Biqqie Smalls is a shareholder, and he contacted investor relations. The person he spoke with said "in a few months," this was last month. So hopefully sometime in August or Sept.

[FearTheLoss]

Biqqie Smalls is a shareholder, and he contacted investor relations. The person he spoke with said "in a few months," this was last month. So hopefully sometime in August or Sept.

I'm with you in believing the results are positive. There is no reason for a company of their size to hold back negative results. I would say 1. the results are great and they are keeping it silent because of patent issues and other companies being able to produce bim. 2. the results are good and they are waiting to see how other trials pan out before spending money on a phase III...either way, it will be interesting to see

[It's2014ComeOnAlready]

Allergan is buying Kythera for $2.1 billion. I find this very interesting, given that Kythera's Chief Medical Officer worked at Allergan for over a decade. Also, they announced trials for Setipiprant soon after the phase IIb studies for bimatoprost were complete for Allergan. I'm sure they knew the results, given the company ties. This is very interesting given the mutual reliance on prostaglandin science.

It looks like Allergan may be trying to corner the hair loss market. Look at this quote in April 2014 from Bosley Medical Director, Ken Washenik:

" The true Holy Grail may come from combining a drug like Latisse with a certain type of medication commonly used to treat allergies and asthma. The medication blocks a hormone-like substance that prevents hair from growing. A treatment like this might help with hair growth. Using these drugs in combination is like taking your foot off-break and stepping on gas at the same time."

Looks like Allergan is trying to corner the hair loss market. Sure, nobody wants a double chin either, but if Setipiprant is successful, it would shatter any earnings made by that injectable fat-burning drug. I really hope this means bim was successful, it may mean just that.