Investor village ISIS board post #46042
OS benefit could be as low at 2.6 months for Synergy trial based on Phase 2b trial OS survival data of 16.9 months from Placebo group.
I keep going back to the P2 results and the fact that -011 got both an SPA and Fast track designation from the FDA.
Scott stated several times that the trial was not designed to be stopped early and efficacy was seen in that iterim analysis as the FDA did not stop the trial. Most on this board think its 50/50 ... i think its 80/20 for positive outcome based on the SPA. criteria
I have been using Bind Therapeutics as a proxy as to what OGXI should be worth via just their 427 pipeline.
It talls me that we should have a free call option on -011.
Yes if -011 fails in the clinic the stock will trade down into the $3/$4 range but would rebound on P2 427 data later this year .
You are so right
way to much HOT $$$$ in this stock
All those MOMO buyer over the last 3 months are bailing because we got no pop today on the trial results.
I'm a buyer on any significant sell-off from todays closing price.
Todays results on the safety side were robust and the drug looks to be active against NASH.
Its a risk/reward investment so need to be a buyer at the right price
not alot of float
news is pending on its P1 NASH drug in Early April time frame.
So lots of investors getting in & out of the stock before this Binary Event.
What scraps ............... I was invested before the Street arrived
Longterm investors like my self who have a very very low Cost basis don't sweat the ups & downs that the markets bring.
Its about management execution, seting the right expectations and advancing the pipeline
Their are only TWO reasons to own any Biotech Stock and both must be positive in the eyes of the investor
Technology, thus the product Pipeline
Dirk is a clown blogger If you had listend to him over the years you would not have put a plug nickle into ISIS and put all your $$$ into ALNY which I made a fortune on like 3/4 years ago shorting it all the way down to $5.
I'm very very very very long ISIS and ARWR, ..................... ALNY is a DOG and that will be proven out over time but to listed to Dirk its Gods gift to the world of Biotech investing A very one sided slanted view by him.
The way he describes ALNY TTR drug is a f**cking joke its 18 months behind ISIS TTR drug its delivered by IV and the patient must be premedicated with Decadron a potent steroid. He touts ALNY's 90% knockdown on IV and disses ISIS 80% knockdown via SQ with no steroids requirement.
Their Drug delivery technology is not yet proven to be safe via having a large patient database .... they can't currently deliver a drug outside of the Liver.
Alny's 5 X 15 program has been on a slow boat to China from a development standpoint. To bad I did not short it again @$110
Bloggers all have an agenda and a following who all get sucked in to what they spouts.
Back to OGXI
There are lots of reasons why the Street does not like the stock aImentioned a few in my previous post..
Dirk has no more a clue that you or me and he is full of BS when he states that -011 doesn't knock down Custersin. He should go read the Journal of Oncology.
yes 427 is a better reason to be invested in OGXI and -011 is the wildcard buts its a wildcard that has an SPA and Fast Track designation. I was invested in Imclone years back and it had an SPA for its MAB and it only needed to show 2 Months of survival in lung cancer over placebo to get approved. Nobody not even king dirk knows the sucess criteria laid out by the SPA. Its a lot less than 6.9 months of OS that the P2b trials generated in prostate cancer.
Time will tell all and June/July is just around the corner
Enough ranting for a cold day in Bean Town
You nor I can' read the tea leaves. Nor Can those clown bloggers
I have a very good understanding of Antisense Technology and its replication of trial results from pre-clinical models to actual clinical results. Clusterin biomarkers where measured after the first dose in the -011 Arm of the P2 studies and knocked down Stat Sig. The drug is active against this target.
The price or the volume has nothing to do with the tea leaves. I can point to dozens of Biotechs over the past 25 years my biotech investment horizon that did not move up or down before a Binary Event.
There has Never been any support from the street for OGXI. The way Management brought the company public via the utlization of another publicly traded biotech. #2) chemo has no future in prostate cancer, not true.
The FDA does not give out SPA;s nor Fast Track Designation unless their is meaningfull data/ medical need to back up the request. The reason for the SPA is to define a clear outcome and OGXI/ TEVA has agreed to that definition of what is STAT SIG and the steps to filing an NDA.
It sounds to me that they have two different paths and the second path utilizes the second -011 P3 trial results.
I for one don't know of one Biotech company that has disclosed the nitty gritty details of their SPA with the Public. Biotech CO's have no requirement to disclose the details only the fact that they had a meeting or got a letter and provide a very high level summary of the said meeting or letter about their communications with the FDA.
TEVA ownes -011 and controlls all communications to the investment community. OGXI is not free to say BOO without running it buy TEVA. Not to say that they don't have a good working relationship, they do one of the best I have seen. The worst I have seen is NBIX and Abbvie ...
If -011 is preceived by the Street as a failure or is an out right failure I will be a buyer on potential 427 results for bladder cancer. yes the stock will trade down to $3/$4 per share
Investor Village ISIS MSSG Board post # 44820
if investors listened to Dirk they would of not invested a plug nickle in ISIS
and volume has been significant over the past several weeks the stock PPS is up 80% from its November Low
I can remember days when 50K shares traded was a very good day
OGXI is not one of those 200M shares outstanding biotechs it has less than 15M shares outstanding
Volume trading days 200/300K are very very big days for OGXI.
And todays price action tells it all
Dirk is a side show that uses conjecture on his part to make some fringe points without the details to back them up. There is a nice post on the ISIS IV board by jetman that you all should read.
anyone who invests on his advise has their head stuck up their (_O_)
We are inside the 30 day window IMO for -011 P3 results
Given the trend OGXI should trade up to around $15/$16 whick equates to around a $250M MKT CAP
I'm in the $40 camp on positive P3 results because cancer has been a Hot biotech subsector and -011 has the potential to be a $1B drug. Chemo is never going to go away as a significant treatment for prostate cancer.
Sooner or later during a patients treatment cycle they will be on chemo thats what some sell-side analyst don't understand. I can see a variety of multiple drug cocktails that include -011
ASCO -011 presentation on P3 results no doubt a late breaking poster.
We get 427 results most likely June/July
Institutions will be loading up and their is only a small float
i have been waiting for it to fall thru $12 as $11.50 looks like the curent floor for support. since the catalyst are all 2H/14 events time is on the side of a lower entry point
Thats about a $55 PPS not unreasonable given OGXI has the option to co-promote OGXI-011 in North America.
On positive -011 P3 data next month IMO it will easily trade into the $40's as we will gain significant street coverage with 12 month PT's in the $60/$65 range. 427 P2 data is on deck for mid-summer.