Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
this is what I wrote at the top on 12/18/17...you guys notice Mr rah Rah was the first the leave when GBTC started tanking???...:).
mact3333 Monday, 12/18/17 11:04:27 AM
Re: None
Post # of 9167
Just sold 75% of my shares while up 560.00 today...been essentially long since 400.00....charts look toppy on ST/IT basis at minimum .
The social indicators all here with the press and the typical rah rah guys on MB's...were getting close.
But i have seen these patterns many many times before, most of retail crowd will lose money on GBTC, that is virtually guaranteed....happens every time...selling into late retail the smart play.
Just remember this, the most ardent guys on MB's will be the first to leave and never come back when it finally pops...remember that.
LOL at all the people questioning Chartmaster and Trend1...they are the only ones that have consistently been right all along....I too called the top within 3 hrs and sold near GBTC 3300 and called for 9000ish on BTC...one more push down to make slight new intramonth low and we should then reverse imho...if this doesnt hold BTC headed to 5000-5500.
Reason GBTC isn't down more today is because people buying for the split and not selling for the same reason...real trading will occur after this friday.
been off loading gbtc shares all week...charts looked bad all week on bitcoin and now its broken...hate to say this but gonna get painful for gbtc for awhile ...bitcoin going below 10K I hate to say...not telling you to buy or sell I could care less either way...just my humble opinion on what Im seeing.
Guys are arguing that were going to 1500 and some saying 5000....dont think either one will happen....I posted on that day we tanked down to 1150 what I thought would happen..and it would be healthy for this to happen...GBTC trades with certain patterns.
What i said at that time imho is starting to play out.
From 1150 we had that sharp dead cat bounce to 2500 and now we will settle into a tight range between 1800-2300 range...this range is abit higher than I thought it would be....think we trade within this range for the next "month"....most of Jan will be consolidation time.
Sometime in Feb bitcoin and GBTC will start moving again...and I think it will be up...will be facilitated and sparked by some "news"...ie-big banks accept ripple like blockchain, government validates and accepts block chain technology...just know it will be big news.
Hope you guys remember this post come Feb.
thx for that chart....nice find.
uh huh....yet volume is like 150K a day lol...up until a month ago avg volume was like 50K a day....:).
wonder why 90% of the trades I see going across are 2-5 share lots?...:)...the GS desk trying to disguise themselves by buying 3 share lots cause they dont want "you" to know they are accumulating hehe.
if you are long, we are on the same side bro...:)....no need to get that way its all good ...I have been pretty translucent in my actions.
un real the jibberish talk on this thread...lol.
the people that are legit are the ones who post in real time when they sell and when they buy.
Last friday, when the sky was falling, there were only a few of us who stated/posted they bought sub-1300.
And go back to previous monday at the 3500 top there were a few of us who clearly said they sold into that euphoria when clear top was in.
Unless you post your trades you could be long, short, no position or a paid shill lol.
but I will make one prediction, relentless thoughtless pumpers on here probably will not make a single dime on this stock when its all said and done....might be next week, might be a year from now, maybe 5 years.
As my previous posts have stated, we would see dead cat bounce to 15000-16000ish level which we already got.
We are at very critical levels right now on BTC....anyone who is saying this is just routine selloff is delusional...we sold off 42% in like 3 days last week...previous selloffs in 2017 were 30%ish at most.
The 12500 level is very important cause if we dont hold that level we will retest the lows near 11200 and if this level doesnt hold the bull mkt on BTC is broken and were testing 8000...and GBTC will follow.
I am long GTBC right now at 1250 and 1700 and will trade GBTC based on BTC charts and critical levels.
Gotta trade what you see....I have seen 10 bagger comes and go dozens of times and this is no different.
The reason there are narrow minded pumpers on every board like this is due to fear and lack of confidence...its tough to hold a stock that moves 25% a day so they have to develop psychological tools to handle the stress and act is they believe with 100% conviction....just mind tricks.
What I would like to see on GBTC is the see the volatility go down and trade within a range of say 14000-18000 over a few week span...then Id feel confident that the rally will commence again but this would only hold true if BTC can hold the critical levels I spoke of above....GL to everyone.
added tiny bit yesterday 1700...added some more at 1200 this am...we should see sharp dead cat bounce up as I noted last night, then modest leakage down...then we need to trade in a range maybe in 1400-1700 range for few weeks...then I see slow rise again and bull continues....if we dont hold 1000 that means the bull is over this will be just another one of the manias that pops that goes down 90% from the highs...but I dont think this will happen.
funny to hear the guys who say I have been in for awhile and Im still green so its all still good(we know this isn't true), and that it doesnt matter...who cares if you bought in at 300 or 2200, when you see the top that was clear as day at 3500 you should sell and buy it back at much lower price to lock those gains in and double up on your profits...jmho...yeah easier said than done but for me, I am NOT willing to give up the profits from GTBC 400.00...worked too hard for it .
I see bitcoin stabilizing at this level 11000-12000 ...anything more and the bubble has truly burst and bull over, which Im fairly certain isn't the case.
One good thing from all this carnage is that certain pumpers(which I told you guy earlier this week will hurt people on this MB with their carelessness) have been humbled and they will think twice before posting ever again.
I am accumulating shares now....starting slow....I see a dead cat bounce followed by slow leakage down ...think we trade in a range 1700-2100 for next several weeks....then we are going higher.
Stops should be in place cause if 1770 doesn't hold were going to 1100-1200...but obviously I think we are holding 1770 since I am buying now.
Just like the board euphoria this monday and the charts showed a clear top...todays panics in late comers and the quietness of the board pumpers says we are close to a bottom.
Greed kills every time....sure you can withstand the vicious sell offs if you got into GBTC at 100-400,. but 90% of the board didn't get in that early...thats why the board pumpers are so dangerous, cause they will blindly pump this stock even at the highs cause they are either naive or have a hidden agenda.
JMHO anyways.
More Bitcoin ETF's Coming.
GBTC will have competition soon...esp a big player like Direxion....there will be inverse bitcoin elf's too so people can go short easily....soon there will be double and triple bitcoin long/short elf's just a matter of time....these are based on bitcoin futures and not bitcoin itself.
Direxion coming soon by summer so there is a monopoly window for now.
GraniteShares and Direxion join the likes of REX ETFs, VanEck and First Trust in looking to create bitcoin-based funds. However, GraniteShares is the only firm among the latest filings looking to launch a product structured as a commodity pool.
only partially true, humans are emotional and behave consistently...usually consistently foolish and people will make decisions based on MB euphoria and momentum...Ive done it, you have done it, we have all done stupid things like this...but you're right, we are all responsible for our own actions cause at the end of day, nobody will take you losses for you, unless you are a wall street bank that it.
Common sense should tell you to go back to the day we were up 760.00 to 3450.00 and see who was selling that day and posting it real time on this board...and believe me selling that day was countertrend and probably seen as foolish cause wow were certainly going to 6000.00 by next week right?...:).
Now you see why I said don't ever listen to the pumper blindly!
It was obviously a sell when we were up 760.00 3-4 days ago, yet the pumper said buy at 3400 cause we will see 5000-6000 within week...many people have lost a lot and will continue to lose a lot of money because of him....he is a guy you shouldn't listen to during a bull or bear mkt....some people are down 45% right now because of him.
And to the ones who say we will see 1200 and if 2000 breaks its over...dont listen to them either cause that isnt happening either.!
All I can say is "were close".
what I posted last night....keep listening to the blind pumpers and this is just a taste of what can happen.
...looking for a specific target before buying again.
I sold most of my shares yesterday while up 675-700...classic euphoric posts(anyone thats been around the block has seen this pattern play out before) all day yesterday....technically a top was in on my charts....sold the rest of my GBTC shares today...read the charts, telling a clear message.
Just be careful people, trade according to your own principals and never ever get caught up with the pumper posts...you have no idea if they are truly long or short ...I'd much rather listen to a guy who posts charts only than listen to the rah rah all day...its fun when everyone making bank but these are the first guys to disappear when the stock gets down 65% and more.
Its usually the quiet guys who have 200-1000 shares.
I still like GBTC and will re-accumulate my shares, but in meantime, we are going down...I will be very surprised/shocked if we gap up tomorrow like some are claiming...this is a classic set up for a overnight trap to the downside imho.
Looking to hit certain levels before I buy...might hit those levels tomorrow.
This stock needs to consolidate for awhile after bottoming.
I sold most of my shares yesterday while up 675-700...classic euphoric posts(anyone thats been around the block has seen this pattern play out before) all day yesterday....technically a top was in on my charts....sold the rest of my GBTC shares today...read the charts, telling a clear message.
Just be careful people, trade according to your own principals and never ever get caught up with the pumper posts...you have no idea if they are truly long or short ...I'd much rather listen to a guy who posts charts only than listen to the rah rah all day...its fun when everyone making bank but these are the first guys to disappear when the stock gets down 65% and more.
Its usually the quiet guys who have 200-1000 shares.
I still like GBTC and will re-accumulate my shares, but in meantime, we are going down...I will be very surprised/shocked if we gap up tomorrow like some are claiming...this is a classic set up for a overnight trap to the downside imho.
Looking to hit certain levels before I buy...might hit those levels tomorrow.
This stock needs to consolidate for awhile after bottoming.
Just sold 75% of my shares while up 560.00 today...been essentially long since 400.00....charts look toppy on ST/IT basis at minimum .
The social indicators all here with the press and the typical rah rah guys on MB's...were getting close.
But i have seen these patterns many many times before, most of retail crowd will lose money on GBTC, that is virtually guaranteed....happens every time...selling into late retail the smart play.
Just remember this, the most ardent guys on MB's will be the first to leave and never come back when it finally pops...remember that.
1. anyone know when Grayscale will distribute the gold part of the dividend.??
2. there are only a few days over the past 5 months I haven't owned GBTC but the date of record for the dividend was one of them so I screwed myself out of a lot of money it would appear. At least I have been long for the most part since GBTC 400.00.
3. lets be clear, unless you are a newby, we have seen these patterns before. We are lucky to have found a sector that is playing the 10-20 bagger game. It is tricky to fully capitalize on this. But moist of the time it ends up badly in the end. Bitcoin might be different as mainstream america just starting to hear about it and use it.
Once you see people calling for 100K-1M for bitcoin you know the top is in...also watch out for your neighbor selling stuff to be crypto trader and esp watch out for bitcoin making the cover of USA today or NY Times on the cover...these are all the social signs of a top. Ive seen it in internets stocks, real estate, and etc. Right now I am seeing everyone saying it a bubble and a crash will happen, so you it won't happen yet.
4. like the sun coming up from the east, the ones who own GBTC will justify its price and will have a great time while running up. The ones who dont own it will use logic and past experiences to down play it cause they want in at lower price. Then the shorts will come in and try to drive it down for profits. Humans are very predictable animals, rinse and repeat.
5. I, admittedly would be up huge, if I would have just kept my original 200 shares from 400.00 . But cant complain. I have held onto my modest core shares and will continue to do so unless it cant hold my stop price.
Yes we are going higher, but I do sense we are close to a ST or IT top this week. Once BTC hits 20K I am expecting a pullback, and when GBTC pulls back I will be adding more shares. I am expecting to see sharp pullback followed by a month of descending wedge pattern of consolidation before the next big run up, I will try to add there. This pattern has played out several times already for GBTC.
Question Regarding Recent GBTC Dividend
So how much was the dividend amout per share of GBTC?..when was this released?.
And which date did you have to have the shares in your account to get this dividend???....thx.
Ocyan, was that your post on the PSA-Rising website???. If so, what an outstanding post!. For Scher to compare NOVC's data to DNDN's(ie-comparing Cox data vs Log Rank) shows his true character or lack of it I should say...but then again, he probably didnt write it and barely proof read it.
May 2007 • Volume 16 Number 5
Substantial Evidence for Provenge Efficacy: FDA Panel
--------------------------------------------------------------------------------
GAITHERSBURG, Maryland—An FDA advisory panel has supported the requested approval of the cancer vaccine Provenge (sipuleucel-T, Dendreon) for the treatment of asymptomatic, metastatic, hormone-refractory prostate cancer. [As ONI went to press, Dendreon received an "approvable" letter from FDA requesting additional clinical data in support of efficacy.] Although members of the Cellular, Tissue, and Gene Therapies Advisory Committee did not formally vote to recommend approval, its members did tell FDA that the data submitted to them showed that Provenge is reasonably safe and has substantial evidence of efficacy.
The decision came after the panel heard presentations by Dendreon and an FDA review team on two similarly designed phase III trials submitted by Dendreon. Neither study met its primary endpoint of improved time to progression. However, post hoc analyses found that the larger of the studies showed a significant advantage for Provenge in overall survival after 3 years. Overall survival in the second trial did not reach significance.
Studies 1 and 2 were randomized, double-blind, placebo-controlled, multicenter trials. Eligibility criteria included metastatic prostate cancer without vis-ceral metastases, tumor progression despite androgen deprivation, no cancer-related pain, no systemic steroids or prior immunotherapy, and an ECOG status of 0 or 1. The primary endpoint for both studies was time to progression.
The two trials used 2:1 randomization, with patients to receive Provenge or placebo three times, with 2 weeks between each treatment. Study 1 randomized 82 men (median age 73; 89% white) to Provenge and 45 (median age 71; 93.3% white) to placebo. The treatment group had a nonsignificant median time to progression of 11.0 weeks, compared with 9.1 weeks in the placebo arm (P = .085).
After study 1 failed to meet its primary endpoint, researchers halted enrollment in study 2 following accrual of 98 of 120 planned patients with similar age and racial characteristics as those in study 1. The difference in time to progression in the second study also was nonsignificant, 10.9 weeks for Provenge vs 9.9 weeks for placebo (P = .719). The two trials found no significant regression in tumor size among the treated patients.
Although neither study specified overall survival as an endpoint, a post hoc analysis of the study 1 data showed an overall median survival benefit for the Provenge arm, compared with placebo, of 25.9 months vs 21.4 months (P = .01). "Overall survival is the least biased, least variable, and most clinically meaningful assessment of an oncology product," said Mark Frohlich, MD, Dendreon's vice president of clinical affairs.
An analysis of study 2 found a median overall survival of 19 months for the treatment arm vs 15.7 months for the placebo group, a difference that failed to reach statistical significance (P = .331). "It should be noted that the survival time in this study was shorter than the counterpart in study 1, which suggests that significant populations in these two studies may not be exactly the same," remarked FDA clinical reviewer Ke Liu, MD, PhD. Dendreon also presented combined overall survival data from the two trials, showing a significant advantage for Provenge, 23.2 weeks vs 18.9 weeks for placebo (P = .011)
Safety Analysis
In its safety analysis, FDA relied on data from the 146 Provenge patients and 76 placebo patients from the two studies. Common adverse events occurring in more than 10% of the treated patients were chills (58% vs 8% of placebo patients); pyrexia (33% vs 7%); headache (19% vs 7%); asthenia (15% vs 7%); nausea (15% vs 8%); paraesthesia (13% vs 9%); vomiting (12% vs 3%), and dyspnea (11% vs 3%). Most adverse events were grade 1-2 and resolved within 48 hours.
Panel members focused primarily on the cardiovascular accidents (CVAs) seen in the two trials, although the differences between the treatment and placebo arms did not reach statistical significance. There were 3 CVAs in the Provenge patients (2%) vs 0 in the placebo group.
The sponsor also submitted CVA data on the three completed studies for the proposed indication: androgen-independent metastatic prostate cancer (studies 1-3), showing 17 CVAs in 345 treated patients (4.9%) vs 3 in 172 placebo patients (1.7%) (P = .092). Deaths attributed to CVAs occurred in 7 and 2 patients, respectively (P = .724).
The panel voted unanimously that Provenge is a reasonably safe drug. However, several members expressed concern about the CVA data and the drug's potential for serious harm. They urged FDA to prod the sponsor to further explore the risk of CVAs associated with Provenge. One panelist declared the agency should not approve the drug until Dendreon guaranteed it would complete an ongoing 500-patient phase III randomized trial, known as IMPACT, that has overall survival as its primary endpoint; some panelists said this study would provide definitive answers to their concerns.
Committee members were less certain about the efficacy of Provenge, with several expressing concern about the size of the trial, the reliability of the survival findings, and whether the lack of meaningful minority participation might hide a lack of efficacy in nonwhites. Howard I. Scher, MD, chief of genitourinary oncology, Memorial Sloan-Kettering Cancer Center, succinctly summed up the survival issue: "The question boils down to: Is this a drug effect or is it related to the patient population?" The committee majority favored the drug-effect alternative and voted 13-to-4 that substantial evidence supports the drug's use in its intended patient population.
Science Behind the Provenge Studies
Provenge is the first of a new class of active cellular immunotherapies to be considered for FDA approval as a cancer therapy. It consists of autologous peripheral blood mononuclear cells obtained from a patient by leukapheresis. The cells are shipped to Dendreon where they are activated in vitro by a recombinant protein—prostatic acid phosphatase fused with GM-CSF—which serves as an antigen. The activated cells are returned for intravenous reinfusion into the patient, where they activate T cells to bolster the immune response against prostate cancer. Provenge consists primarily of CD14 and CD54 monocytes, CD19 B cells, CD3 T cells, and CD56 NK cells.
are you the same same Dreday from PXF and PS's???
what if the person held the bat upside down and he still hit .335 with 40 homeruns???...:).
really, I agree with Bob...if the primary endpoint was met with flying colors, do you really think anybody would care if DNDN couldnt explain the MOA very well??...well theres your answer.
BTW, I dont care what Bob says Im agreeing with him cause he is a RO..:)
to me, if the numbers were too small to be approvable to begin with and if the OS data was hypothesis generating only because they missed the primary endpoint end of story, then why bother with the AC meeting or even allow DNDN to file to begin with???...either the data is good enough to be approved or it isnt...if the data is sufficient to be evaluated for approval, then the data should have led to approval.
I didnt listen to the AC meeting but I did read alot of it...I agree that DNDN imho did a horrendous job arguing on their behalf...I seriously think many on this board could have done a much better job.
And I still dont buy that Dr Small's flight was cancelled and thats why he couldnt make it...just cant buy that one at all...also, Dr Small is never quoted regarding Provenge anymore...his past views on Provenge seem very timid to me...now when you hear the principal investigators talk about Satraplatin, they will go beyond over-zealous on the TTP, DFS and time to pain data...we need a spokesperson(oncologist) who will go to bat for Provenge...find it odd that the most outspoken person in favor of Provenge is Dr Penson, who showed up to the AC on his "own dime".
Dew/Wall/Clark:
Hypothetically speaking, if DNDN mgt went through the 9901 data again and found another so called "clerical error" and the primary endpoint TTP came in at or less than p=0.05, would the OS data be seen as legit by the FDA???. If this did happen, could they refile with the new data???. I realize that 9902 wasnt significant by itself but given the small pt size and limitations with this, I still think it could be argued it was "supportive".
To me, I cant seem to understand why DNDN mgt didnt fight to the death arguing that the TTP p=0.052 was statistically significant...they even accepted the incorrect p=0.08 in the briefing documents...why would mgt do that when the OS data was being discounted due to the primary endpoint miss.???
Everytime I read about the DNDN data I keep hearing that the primary endpoint was missed but they never state it came in at p=0.052...I personally dont consider that a miss and perhaps the company should have been arguing this every since the data was published in the JCO.
Guess my question is this, if the TTP was p=0.04 for the sake of argument, would the FDA and people like Scher/Hussain have accepted the OS data? I realize that OS wasnt the primary or secondary endpoint.
OT: Does anyone know of any companies that have open enrollment using immunotherapy(not intra-bladder) for advanced bladder cancer????TIA. Did Google search and couldnt find anything, just found results of outdated immunotherapy using BCG/IFN intra-bladder treatment.
to be honest with you, I dont know but my guess is that SPPI will ultimately do better...this is counterintuitive because SPPI only gets 10-13% royalties of revenues from future sales from GPCB...as you know, there is arbitration going on right now because, for lack of a better word, SPPI "screwed up" and sold the rights to GPCB and then GPCB sold euro rights to PHRM....good news is this, at least SPPI doesnt have to invest in the infrastructure to make and market the drug, they can just reap the benefits if Satra does get approved...also, SPPI has several other promising drugs in phase II for BPH and superficial bladder cancer...the mtk cap of SPPI is very small(160M if I recall) and GPCB's is close to 1B...I have taken a larger stake in SPPI than GPCB(hate buying those ADR's)...I think its quite likely that Satra gets approved for all the reasons mentioned today by the other MB posters...its sad but SPPI/GPCB mgt. just knows how to play the game better than DNDN mgt...guess surrogates for survival is more important than survival itself!
SPPI/GPCB will announce news next Monday regarding TTP and time onset to pain and its significance...wont be earth shattering news by any means but should shed some more light on the SPARC data...SPPI was supposed to announce OS data this summer but now they think it will be by years end...given this is a event driven process, this tells me that the pts(median survival should be roughly 10 months in this setting) are living longer than expected and it was a 2:1 randmonization in favor of Satra arm....but more importantly, this data wont be released before the PDUFA date hence it isnt a risk either way.
One thing for sure, if it does get FDA approved as everyone is expecting in July/Aug, the stock price of SPPI and GPCB isnt going down thats for sure.
FWIW, I just tripled up on SPPI and GPCB...I think there is a 85-90% chance Satra gets favorable AC vote in July and gets approved in August...while it wont take off ala DNDN after the AC meeting, I do think the PPS could double...Satra is no Provenge, but pathetically, this what the FDA wants...at this point, while I will cont. to fight for Provenge, I need to make up some of my paper losses from the DNDN fiasco...:).
I dont believe the OS results have been released yet...I think you are alluding to the PFS curves...and unlike what you said, they seperate early, middle and late....here is Dr Bajorin's quote regarding this.
<<<<< Figure. Dean F. Bajorin, MD: While the absolute benefit of satraplatin plus prednisone in reducing the time to progression was only about 10 days, the regimen could be a valuable second-line treatment option for men with hormone-refractory prostate cancer. You have to look at the curve, not at a point on the curve. At any point in time, patients in the study taking the drug were one-third less likely to progress than those who weren't.
While the absolute benefit of satraplatin plus prednisone in reducing the time to progression was only about 10 days, the regimen could be a valuable second-line treatment option for men with hormone-refractory prostate cancer, said the moderator of a news conference that featured the study, Dean F. Bajorin, MD, Attending Physician at Memorial Sloan-Kettering Cancer Center.
You have to look at the curve, not at a point on the curve. At any point in time, patients in the study taking the drug were one-third less likely to progress than those who weren't.
Since the median survival for these patients is typically only eight to 10 months, and patients usually get very sick very quickly, the difference between the curves is more important than the median difference in time, Dr. Kelly agreed.
The curves separated early and continued to separate. By six months, there was a large difference in progression-free survival. Patients who dropped out did so quickly because they got sick or couldn't tolerate it.
The bottom line, he said: There is a subgroup of patients who will benefit if you give the drug long enough, and we are starting to figure out just who these patients are.>>>>
Timing of CR Letter and Todays FDA Guideline Announcement:
As noted before, I placed odds of approval at 75-80% so a approvable letter wouldnt have been a complete shock to me but I was shocked at the timing of the CR letter...for what purpose would you need to send the CR early?..now a full out approval being announced early I could see.
Well now they release the new FDA Guidelines today and after a brief glance it seem to favor the Provenge application.
Perhaps they didnt want these new guidelines in place when final decision on Provenge made??..not sure but kinda strange.
Clark, I do not think the CVA's seen has anything to do with brain met's...in my 10 yrs in oncology, I have only seen 1 pt that had a true parenchymal brain met in a met prostate Ca setting...I have seen a few with leptomeningeal dz and obviously alot with cranial bony dz...so its extremely rare to have a brain met from prostate cancer..getting back to CVA risk, could it relate to the Provenge.. maybe???...but not likely imo...the CVA p value came in at 0.8 if I recall...thats not to say this wouldnt turn into 0.05 if there were a 1000 pts on 9901/2a but given the small number of pts in 9901/2a, I wouldnt put too much weight on this although the FDA will given their current paranoia on all drugs with potential CVA risk...funny thing is this, if Scher/Hussain/Fleming are not willing to accept the p=0.01 OS data because the primary TTP barely missed at 0.052, then where do they get the nerve to bring up potential CVA risk coming in at 0.8?. If I recall, Taxotere leads to a 2% death risk from the taxotere itself..how come nobody talks about this risk??? And when you ask MO's about it, they says its ok because the small OS benefit outweighs to death risk from Tax itself in a end stage setting...a double standard here????
I know that all trials using Avastin will exclude pts with brain mets due to CVA risk...the lung Avastin trials also exclude SCCA's due to fatal pulmonary hemoptysis risk...its ironic cause pathologically, Avastin seems to completely obliterate the tumor and the blood vessels in some responding pts...some think the response is too good.
The CC was much more informative than I would have thought.
First of all, I sold my entire position yesterday morning and I am glad I did(thx Wall)...I thought we had a 75% chance for approval so an approvable letter at 25% chance wouldnt have shocked me by any means but what I wasnt expecting was an approvable letter before 5/15!...in other words, didnt hedge in time...oh well.
Gold actually revealed more than I thought he was going to today.
I was just going to forget about DNDN for a long long time but Im not so sure about this anymore. Gold said a few things that made me rethink this. I will most likely buy below 4.00 now.
Here were my concerns before the CC. I pretty much figured that 9902B survival data was going to be needed before filing again(hence nothing to get excited about til 09-10'). I was concerned about the interim look of 9902B also. My concern dealt with the pt's in 9902B being sicker(ie-minimally sx-atic this time), how much alpha the co. was going to spend on the interim first look and lastly , the crossover issue.
Gold made it very clear that the demographics of the pts in 9902B were very similar to the pts in 9901...so maybe they are not that much sicker...Urdal said that survival between a-sx-atic and minimally sx-atic was similar...Gold appeared to hint that perhaps we should expect similar results?...in my mind, he also confirmed that they understood the gravity of having positive data and momentum by next yr since funds will run dry by middle of next yr imo...he verified that they will spend enough alpha to allow the interim first look to be meaningful...we can file again if the interim look is significant(as noted in the SPA)...lastly, the thing I didnt really appreciate regarding the crossover issue is this, he noted that the Provenge that the crossovers receive isnt the same as the pts in the tx arm receive and the crossover Provenge isnt as powerful...did I hear that correctly?...well, although I'm not going to rush out and buy any DNDN shares tomorrow, it does give me some hope that we can start to take a position again perhaps late this yr or early next yr if we get guidance from the company that doesnt scare us away...actually, anything in the 3.00's is fair imho.
On a side note, I felt really horrible yesterday and today cause one of my pt's with rapidly progressing prostate cancer was really hoping Provenge would get approved...he is scheduled to start Taxotere next week and he really doesnt want to secondary to the SE's. He wanted Provenge!. I felt even worse cause he told me a few days ago that he bought DNDN last week to support the company...so not only does he not get Provenge but he takes a 60% haircut...now that really pisses me off! I am going to contact Dendreon and see if he can have access to Provenge even if he has to pay for it himself...he is too advanced to be on 9902B.
I see this guy as friend and a patient and if the FDA(Hussain/Scher/Fleming/Pazdur/Witten/Goodman/Von Eschenbach) could see pt's this way instead of just a disease or a statistic, Provenge would have been approved...these MD's have lost sight of whats important...while I would agree that you cannot bring drugs to mkt with weak data packages but for end stage incurable cancers, the bar has to be set lower especially if the side effect profile is good like Provenge...if my daughter was dying from incurable cancer and there was a drug that missed the primary endpoint by 0.002(ie-0.052 vs 0.050) and there was 3-4 fold OS benefit and someone told me she couldnt have access to that drug because the primary endpoint was missed hence the OS benefit was hypothesis generating only I would punch him(maybe even a her too) in the face I kid you not...any reasonable parent would!... so would Scher and Hussain, thats the sick part of this.
Ok, Im going off on tangents so now I will stop.