First of all, anybody is listens to wildbill, doyoulikeneruda and others of their ilk, need to have their heads examined. These pumpers are idiots and cheerleaders only. They lack substance. Now rajlonghorne claims to be a doctor and is trying to influence you to buy and hold. Should you do so based on raj's advice, then you truly are a gambler. I endorse him somewhat in that he does caution his advice with the warning that you could lose your entire investmentment. That being said, now pay attention.
Ray says the PEARL studies are irrelevant. Affymax's 2012 10-K doesn't think so, but you can read it yourself and I do not want to reprise. As I have said from the very first publication of the Fresenius letter consistently, there is more to the recall of Omontys than just the Anaphylaxis reactions. Read the WSJ article. If it were only "benign" Anaphylaxis reactions, then Omontys would be a relatively easy fix. But the PEARL studies, which longs seek to dismiss because of the limited number of patients enrolled in the studies, show that Omontys kills healthier CKD patients instead of those on dialysis. Such a finding does not make sense, and even Affymax admitted the finding, in its own doctor's words, was "inexplicable" and one
"for which there is no definitive answer"/ With Fresenius 25,000 patient base data, I believe that the statistics verified the PEARL studies unsafe profile and that is why Takeda/Affymax cannot get Omontys back on the market shortly. It explains why Affymax's latest 8-K said there were discussions with the FDA concerning withdrawal of Omontys New Drug Application. Everything has been disclosed, it just takes some understanding of the health care system and how the FDA works to discern that Omontys is a dangerous drug for which there is no unmet medical need. Actual patient usage discredited the EMERALD study. Omontys is a failed drug for which there is no unmet medical need.
WSJ article was planted by Shorts. Do you believe that all journalism is "fair and balanced?" Of course you don't. You yourself misrepresent yourself. Example one: you are not a legitimate short - you are rather a paid basher. It is easy to conclude thusly as you have lied about your own intentions on this board.
You dare to engage Raj head-on? I am glad to see him take your head off.
God Fraud - you have been exposed as a fraud.
Don't you dare misrepresent me. I am no pie-in-the sky pumper paid to appear here. I am a successful small investor (with law degree - just as you claim) who has made over $1 million net by speculating in biotech stocks.
AFFY is a very good speculation here. May it go BK and end up at 35 cents a share? yes, possible, though not probable. Does its drug work? yes, see Raj's comments. Why is AFFY trading at $1? Shorts and naked shorts have pressured it and MM's have accommodated them. Has management mis-managed the crisis? yes, of course. Can Omontys be salvaged? Yes, unequivocally. Is real value here more than $1.02? Yes - value of drug as-is is at least $5 - $8 per share or up to $300 Million.
God Fraud - we have your number .... you will not be allowed to spew garbage on this board nor malign me personally.
What do you think about this ongoing Affy Phase 2 study that was updated in April 9, 2013? "The purpose of this study is to evaluate the ability of peginesatide to increase and maintain increased hemoglobin levels in participants with chronic kidney disease (CKD) (either not on dialysis, receiving regular hemodialysis or peritoneal dialysis, or following renal transplant) with confirmed antibody-mediated pure red cell aplasia (PRCA)."Estimated Enrollment: 40
Study Start Date: April 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
auto immune diseases are always tricky and looking at their clinical data thus far, i don't believe that this venture will come to anything meaningful. OMONTYS is in essence far too powerful of a drug and thus utilized only in the sickest CKD patients on dialysis.
Epogen does have an upside when it comes to this orphan indication because its not as potent and thus the dosages can be calibrated depending on the severity of the patients condition. gwp believes in only telling partial truths, but i believe that the truth is important beyond simple personal gain.
I believe this continual bickering between those of us who are long, compared to those who are short, admittedly gwp himself; will come to an end. I do foresee an announcement coming within the month.
P.S. AFFY is extremely high risk, don't invest your money that you cannot afford to lose.
I have been waiting for you to come out of your cave all weekend so that i may discredit your points face to face. As you continue to stray from an outright discourse with me, i take it that you are obviously afraid. Now let me try to clarify the PEARL studies yet again, perhaps it will finally make sense to you.
OMONTYS was FDA approved for Chronic Kidney Disease patients who are on dialysis only. The "only" part is important. OMONTYS being an ESA, which in layman's terms, increases the amount of red blood cells in patients with Anemia. All three FDA approved ESA drugs have a dangerous profile but the only other option for these patients would be blood transfusions, which can cause MODS is some patients and death.
So, to explain it simply, yet again. The increase in red blood cells, increases the patients hemaglobin/hematocrit levels and an increase of hemaglobin levels greater than 11g/dl can cause patients to have an MI or stroke. OMONTYS works far better than its competitor Epogen and since the kidneys are damaged in these patients, they cannot filter out the drug appropriately. The reason for the PEARL vs. EMERALD studies was to all evaluate the pharmacokinetics of the drug and how it is excreted from the body.
OMONTYS requires 1 single shot per month compared to Epogen, which can require up to 15 shots per month to produce any clinically significant rise in H/H, which is defined as greater or equal to 5 % in patients deemed to have severe anemia.
Your blatant disregard for the information can only be perceived as a uneducated or a willful act to misinform. As i have stated in the past, AFFY is a high risk investment; however, I will not stand for your lies.
PEARL study has nothing to do with the current clinical indications of OMONTYS, your continual need to reproach the subject shows your desperation. I look forward to correcting any other misconceptions you have about medicine as you continue to show your ignorance on the matter.
"OMONTYS works far better than its competitor Epogen and since the kidneys are damaged in these patients, they cannot filter out the drug appropriately."
That's another good point as to another was Omontys meets this unmet need the short grunt is talking about. I have to laugh every single time I hear about this PEARL study again and again which all it did was pass its primary endpoint like the other four studies. The recall was not even based on cadiovascular significant event, but a simple allergic reaction. OLD NEWS!!! Enjoy the shiny new nickle your short grunt overlords gave you for another response.
By the way, there is no way the fraud is still shorting from $15... so he can make another 6.67% on his money? I guess he thinks when you short you can make more than 100%. If he's still shorting he's the greediest pig alive and we all know what happens to bears, bulls and pigs.
Sentiment: Strong Buy
The PEARL studies not only showed high incidence of elevated hemoglobin, which as you rightly say can contribute to MI, stroke and NSTEMI, but also Stevens Johnson and other allergic manifestations. Raj, you are a biostatistician, I know you! Call the evil Francisco out
Raj - God Fraud merely regurgitates what an analyst with an axe to grind has to say about Pearl or Emerald studies. He himself has said in previous posts that he lacks the technical expertise to analyze these studies on his own. His role on this board is limited; he is merely a "mouthpiece" - admittedly a very loud and obnoxious mouthpiece - for his paying customer. In fact, God Fraud is an elite basher. He does not merely scream obscenities at Longs - instead he is more insidious - he misleads, distorts, misrepresents - and he passes along "analyses" regarding AFFY that is biased and planted by the Shorts. The way he speaks in reverential tones about Amgen, it makes me wonder if Amgen is not his client.
No matter - you Raj, have helped to discredit him. I will do my part to keep this board clean.