It seems fairly evident from reading this board that most of the material posted is not in the least helpful and there are a significant number of bashers who run rampant like a plague. Now this is my opinion and observation and you can choose to disregard it, but here it is. OMONTYS is a once-monthly erythropoiesis-stimulating agent (ESA) for anemia primarily used in dialysis patients, most of whom have treatments MWF or Tuesday&Thursday. This drug is used to keep their hemoglobin levels up but can put them at risk for stroke or MI if their hemoglobin goes in the excess of 11g/dl (grams per deciliter). For normal healthy males the level is 14-18 g/dl, females 11-16 g/dl. The current standard of treatment is Erythropoietin (EPO), a synthetic form of the hormone that is produced mainly by the kidneys (before they were damaged). EPO shots are given quite frequently and it can take a month or two before a significant enough rise in hemoglobin/hematocrit levels ( 5%) for the patient to start feeling any better. Epogen is made by Amgen who is about to lose the patent of this inferior product, opening itself up to generic competition. OMONTYS is a significant improvement over EPO and will become the standard of care in the near future at dialysis centers across the country. OMONTYS was recalled voluntarily by AFFYMAX and its partner TAKEDA. TAKEDA (TKPHF) is an Asian based pharmaceutical company out of Japan with a market capitalization of 41.28 Billion as of April 5, 2013. The reason for OMONTYS recall was due to allergic reactions caused by the drug in 0.2% of the patient population that was administered the drug within the first 30 minutes of administration. These allergic reactions turned into full blown anaphylaxis in some of the patients and caused the death of 0.02% of 25000 plus patients that were treated by the drug. Any competent physician should know that anytime a patient is given a drug for the first time, they should be closely monitored for an allergic r
I just read an article about dialysis from December 2010. Called “God Help You. You're on Dialysis,” it was published in The Atlantic and discusses the kind of care that is typical at dialysis centers in the US. This is not a pretty picture. We need to thank our various gods for healthy kidneys and try our best to keep them that way!
I get to see dialysis patients on a weekly patients and they truly are some of the sickest patients out there. For a healthy individual eating an extra meal or drinking a couple of extra glasses of water is no big deal but for these patients who don't follow their fluid restrictions, it can be deadly. Since the kidneys are not working in these patients, their blood pressure increases significantly, they have peripheral edema (swelling to extremities), ascites (abdomen swells up due to excess fluid) and they may have flash pulmonary edema from least bit of exertion. Pulmonary edema is a disease state in which the plasma portion of the blood crosses the membranes and ends up in the lungs and literally drowns the patients. The only treatment for these people in the emergency setting is a CPAP or biPAP, where an airtight mask is placed on their face and forces air down into their lungs. AFFY actually has a drug that helps them but sadly caused a reaction in 0.2% of the patient population and was pulled, their current regiment is EPOGEN, which some of these patients have to take up to 15 times per month instead of the once a month OMONTYS.
Sentiment: Strong Buy
strong buy if you are just getting in now, to all those who fell from mount Olympus; my condolences. To the bashers, harassers, and haters, you are God's Special Children. GOD bless your heart.
If you dont believe in the company or the drug, then sell sell sell.
BUt please make an educated guess. You an always make more money, as long as the intellectual capability, emotional Dexterity and the will to succeed are within you!!1
Sentiment: Strong Buy
Raj - please keep on posting this message from time to time. I try to keep the bashers honest. I do not have a medical background - but I have been a speculator my entire adult life, have significantly more winners than losers, and my fair share of common sense.
Like many, my focus is on the 25,000 patients who have used Omontys and the related doses which must number at least 100,000 (once a month X 4 doses before recall - maybe the number is doubkle that or more) and the low number of allergic reactions.
Were the drug as deadly as the Bashes maintain there would have been scores of deaths and thousands of allergic reactions. Instead we had a fraction.
Why did AFFY fall so hard and so fast is the same reason why it can rally very hard - the biotech sector is the most volatile sector in the market. Naked shorting and to be honest some ludicrous PR's from AFFY brought us to the 1's. A decent PR and with covering AFFY can climb to the $4 level in the blink of an eye. Then with solid good brews further gains could be possible.
If you have any insights into the limitations of the Pearl study I would appreciate your input. I understand the study was 200 patients - a slim number indeed. The results have been construed as sub-par by Professional Bashers. I would like to contrast Pearl with the 25,000 patients who were administered "O." Again, any insight would be welcome.