"Anyone who thinks that they are doing this because they feel 3&4mg data wasn't good just isn't paying attention - they made it very clear that now that they are involved with the FDA, they can only release full data sets - if they are going for FC's "
come on man, look at their past behavior... they didn't think twice about talking about unblended data last year, even going on CNBC to hype their thesis. these guys aren't doing this because they suddenly discovered the concept of discretion. and no there is no requirement to not release it at all.
I hope you're right, but this is starting to be a problematic pattern of getting people excited about specific timeframes and then missing them.
ALNY's rise is actually more puzzling than ARWRs lack of rise... I still believe there's some sort of Hedge Fund long/short pairs trading going on there.
your pumping Is so bad its shameful.
what happened to all of Anazalone's previous clinical candidates? not like he has a good track record.
ARC 520 is exciting, but it would truly be the first successful study in 10 years of the this company's haphazard history.
Adipotide phase I study? completely dropped from mention
CALAA - 01 study? completely dropped from mention
Shire peptide partnership? completely dropped from mention
what about the other great 'platforms'?
"This breakthrough evidence provides important validation for siRNA-based therapeutics in general, as well as for our proprietary RONDEL delivery system, and for our lead siRNA therapeutic candidate, CALAA-01," said Dr. Christopher Anzalone, CEO of Arrowhead. "We congratulate the investigational team for their exceptional work and are gratified that our many years of support and investment in this technology have made this moment in medical history possible. We believe we are nearing the time when siRNA therapeutics can begin to make a historic leap from science to applied medicine, where it can truly make a difference as viable treatments for patients with a variety of prevalent unmet medical needs.
Commenting on the partnership, Dr. Christopher Anzalone, Arrowhead's President and Chief Executive Officer, stated, "We strongly believe in IT-101 and the CyclosertTM platform, and this transaction goes a long way toward achieving our dual strategy of decreasing costs while working to monetize these potentially powerful assets. We believe that Cerulean will be a terrific partner given its focus on nanoparticle-based drugs, strong financial position, and high quality management team. We look forward to our mutual future success."
for some reason Yahoo deleted my earlier response with a link to NIH. but it turns out the NIH later in 2013 (November) resumed recruiti8ng for CHimp studies, but set a variety of new oversight panels and rules for their care.
CNN published earlier this year that only 6 of the 300 + had been 'retired'.
on a positive note I think Texas Biomed and MD Anderson are very active in accepting studies for their 600 chimps.
on a negative it shows how pathetic our govt is in terms of keeping their word on anything.
not a chance. ARC 520 is a candidate to REPLACE interferon. interferon is miserable. the whole point is to get rid of that treatment!
I"ve watched or read all of them. What I note is that indeed the science is usually very interesting and points to interesting possibilities for further research, but often that doesn't help make the BUSINESS outlook any different in terms of cash flows, cash needs and so on. So the issue we have as shareholders is will the share price react positively or negatively based on certain expected data points?
My take is the hurdle is quite high, as for some reason this stock is guilty till proven innocent. Therefore it will require some remarkable efficacy data to change the outlook for the company.
More important to wall street and institutions are these items:
1. when does the multi-dosing protocols at 3-4mg get approved (asia / Europe) to get the bus going on that data
2. when can investors see actual efficacy data in humans that shows it has a benefit to humans at some dose? 2015? 2016? (Tekmira just taugh a bunch of people a real hard lesson about efficacy in primates vs humans on their ebola drug)
3. will the data shared drive research cost estimates and timeline HIGHER or LOWER?
4. Does the data show that ARC 520 may have a benefit that complements other drugs in research by Gilead? (rather than as an alternative to)
5. Does the data show ARC 520 as a potential alternative to IFN ?
Those questions will drive the price, NOT whether the research is 'seminal', 'promising', 'interesting', 'pointing to new theories', 'changing dogma'.
institutions will wait to see real efficacy before making a big bet, especially after TKMR blew up after great primate data on ebola
they added cohorts to the phase 1A 1-4mg that are just now enrolling and dosing. they can't unblind the 3-4mg data until the new cohorts are done next quarter. THe new cohort ideas come from the secret 9 chimp study no one knew about.
Analyst day sometime next quarter. not specified.
FDA now wants to see all single dose data results as well as 9 chimp study results before any multi-dose study greater than 1mg will be consideredin USA.
Anzalone careful to note that doesn't prevent multi-dose outside of US in asia and Europe.
my personal conclusion only:
data from 3-4mg was not as good as expected. therefore mgmt. shifted gears to add interferon and other additional drugs to the 3-4mg study to look for better results. likely they saw increased efficacy from doing this in the chimp study.
otherwise they would have gleefully announced the 3-4mg data results if they were positive.
not baffling at all. Wall street has a 1 yr outlook and they invest in things with a one year 'catalyst'. mgmt. got everyone excited 18 months ago that they were on a fast track to a HBV drug. then Sovaldi blew everyone's mind on the potential of Hep treatments being at $80k per treatment. So wall street got excited.
but now WS realizes with each passing quarter that the approval process is being delayed by FDA, and requires a lot more research, which means more fund raising, more cashburn, and more years. Meanwhile competitors benefit from ARWR doing all the safety studies on RNAI and get to 'catch up'.
the original assumptions were unrealistic, but remember those assumptions came from Anazalone who promotes the story at every little bio day at every investment bank out there. so he set the expectation.
The science may still work out, but its going to take another $250mill fund raising within a year. that's going to be tough to absorb if they don't have human efficacy data or partnership by then.
Chimp efficacy doesn't get it done. we know that.
not a mystery here. lots of interesting things going on, but human efficacy data does not exist at this time. still pure research vehicle burning through cash at $28 mill per quarter with 4 quarters left before secondary needed.
you should not screw around with options. you are not experienced enough. 85% or more options expire worthless. do you really believe you are the smartest 15% of the entire investor market? make money investing for a bunch of years and build up a cache. sell calls to start. read Natenberg's book. if you can understand that book and master it, then start trading options. you're not ready
Its very hard to assign any value on it as its so vague in terms of the benefits to DPC.
but I find it most interesting that Novartis sold it to ARWR and not ALNY. Novartis was a HUGE partner for ALNY ... they had a 13% stake in ALNY , and they not only ended the partnership, they sold their investment, and then sold the program assets and ALNY's IP access to Arrowhead. that really says alot about what they think of Alnylam.
now what does it mean fro ARWR ? Probably nothing for several years. I suppose the bet is that the molecules can be used with DPC and be more efficient. But that will take studies to discover and validate.
What would be interesting and validating is if ALNY licensed more DPC rights for other drug development efforts ( think ALNY licenses and uses DPC for one now). That would validate that 'there's something there'
not to worry, if a single human experiences 6 months of 'functional cure' we'll have 5 big pharma's wanting this. what we need to worry about is the speed and quality of clinical results.
what if they found out ARC 520 side effect was reducing adipose tissue in women by 1% per month of intake... screw HBV
doesn't matter. no value is attached or removed based on that suit for institutional investors. its about the study results in humans. either there is efficacy and safety or there is not.
don't worry about the ambulance chasers, they have to pay their 3rd wives alimony somehow.
people reallyrunning with the excitement in this here thread. wow.
what is the addressable market for ARC AAT? what is the addressable market for oncology treatments? a bit different eh?
As you stated the issue with this company is not the intriguing technology platform, but management. the jury is out on whether this management team knows how to convert someone else's discarded IP into a income generating asset. certainly if this mgmt. team where in the nfl draft they would go last round or undrafted at all based on record.
I continue to believe that this mgmt. team needs badly both cash and credibility and can't do that on their own. If I had their ear I would strongly suggest a partnership with some large bios to develop DPC jointly into a broader delivery IP asset faster. If the DPC tech can be used outside liver targets then the range of targets is massive and they would be best served running 10 studies at once targeting different tissues to prove efficacy.
this strategy of spending their entire cash reserve on 2 targets but retaining most of the rights is so risky and the biggest risk is just time. What if they find HBV to be too tough and really its some cancer treatment delivery mechanism that works best? that outcome wil destroy the equity value.
I've seen this before and they really have bet the farm here on this AD. I see that is a poor and risky strategy confirming that these guys need a more experienced partner (GILD? JNJ? Baxter?)
yeah, 'front end' is a way of lowering expectations. put it this way. we can win in 3 ways:
1. they show consistent immune response with xyz combo
2. they show immune response from ARC 520 as good as Interferon
3. They show FC (highly unlikely)
any of those will propel shares higher to varying degrees. But if none of those, then its back to $5.
naturally if they do show FC in 1 or more chimps then this thing will triple in about 5 seconds.
I believe 'provisional patent filings' are non-public. THey can be filed up to 1 year prior to the actual patent request. So I think... that they could file the provisional description and art and keep it secret for a year.