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
yes indeed. but again mgmt. set that goal! the best outcome for shareholders is it requires a year of therapy or even ongoing therapy. however that will also be very very hard to get the FDA to allow the trials for such an extended duration with an experimental substance hitting directly to the liver. cancer risk
The primary source of confusion is mgmt. continually referring alternately to results from single dose vs. multi-dose and 'hinting' at the result. that has confused everyone including investors. THey need to stop doing that.
WHat I believe is they are close or reached FC in chimps with a combo drug therapy and a different RNAI profile version of ARC 520 in a multi dose 9 month chimp study.
I believe the single dose human results have not hit 1 log in 3mg or 4mg so they are going to disappoint when released. Mgmt hopes that the chimp data will prodive the basis for expanded human studies mixing in the interferon or other ancillaries.
However the risk here is that at least in the USA, the FDA is going to require a full completed 1mg multi dose study completed before approving a higher multi-dose study to proceed, that means 2016. In addition ARWR needs to raise additional cash by Q1 next year, so whatever they plan for this analyst day had better boost the stock substantially so they can then raise a $200mill or greater amount to proceed with more trials and more time to accommodate FDA.
here's the good part for investors. if we assume that the 9 months chimp study showed a FC or close, it means that should the drug be approved it will require use for 9 months or longer, and that means a higher revenue profile if its every put into use.
yes that person is not making a smart move.
1. the time decay kills the value since we know nothing will happen in next 60 days, there is no reason to jump in now.
2. The expiration date gives no real chance of the event taking place prior to expiration.
better approach would be selling puts, or as you indicate buy the Jan 16's but wait another 45-60 days.
I think selling puts here with a sept exp. makes more sense. if you get the stock put to you, who cares you are more long.
are you new to this?
everything they've published has taken longer than expected. the FDA could say 'we'd also like to see xyz now'.. or participants may drop out. its a short timeline.
earlier this year we expected multi-dose trials from 1mg to 4mg starting in Q2, now its more like Q4, or 2016...
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.
that says a lot. if you thought you were onto a major discovery that was going to send your shares up 10x you'd be buying every share you could ...
till I see random officers buying I don't think they themselves have conviction yet
this echoes my own concerns. when a bio truly believes they're onto something big the insider buying is rampant. they tell everyone they know to buy.
I've been long and interested but its now starting to smell ... going back to chimps during human trials makes zero sense unless your human data falls short.
Well it would have been nice if mgmt. had really been open and let investors know the reality of their mgmt. style:
1. they will provide very clear expectations for data and timing, and then change their minds at the last minute.
2. they will sometimes release data that is blinded and sometimes not, depending on their whim
3. they will buy up random assets without disclosing that as a strategy
4. they will grant themselves compensation at rates below secondary investors regardless of performance
5. They will selectively disclose key info to random retail shareholders via email rather than to investors on official calls
6. they will raise cash for specific studies, and then run secret studies on the side no one is aware of
which of these sound slike a strong mgmt. team?
"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.
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.
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.
The problem with Dirk's blog, while it makes for interesting and educated reading.... is that it is 90% speculation. If this, if that, assume this, assume that... ok fine.
exactly. Dirk H. was being 100% sarcastic. LOL.
you got to be wary of this Dirk H guy posts. He pumps whatever he's long at the time.
He dumped his ARWR when the 1-2mg data came out at $11 or so. or so he claims. Then he loads back up in the 5-7 range and starts pumping again.
The guy is a promoter of all things RNAI in research stage as he loves the ideas. But he also trades all these often and doesn't tell his blog readers he intends to trade them ahead of time.
Don't get me wrong, I appreciate his insights and posts. He makes some of the obscure stuff understandable. But you can't and should never trade of some guy's twitter feed comments.
there is not evidence that any of the multi-dose trials have started. We rea`lly need them to get a multi dose started with at least 2mg