As we can not read "between the lines" nearly as well as you.....""The vast majority of patients who are receiving the medication on an ongoing monthly basis are tolerating it well" and "For patients on Omontys, we recommend continued use of the agent as it has been providing effective anemia management"
Break it down for us will you godwinpeak ?
Yes, we is real dummies, edgeamacate us please.
I will do my best to edgeamacate you, but I am certain it will be to no avail. Simply put:
1. Serious "inexplicable" and serious adverse reaction discrepancies between the USA based EMERALD studies and the European PEARL studies. Interestingly, dialysys anemia patients are usually "sicker" patients, yet showed little serious adverse reactions to Omontys than chronic kidney disease patients not on dialysis. "We do not underestimate this safety signal. It [is] something we need to investigate and find out more about. But at this time, to file for [chronic kidney disease] patients would be suicidal. The FDA probably would not go for it right now," said Dr. Schiller commenting on the safety discrepancies in the two studies. (Medscape Medical News May 18, 2012). Also, Omontys a not insignificant number of Omontys patients have developed neutralizing antibodies to Omontys which lowers efficacy and usually mandates a switch to the Amgen medications.
2. Omontys sales are significantly below analysts estimates. See Q4 Omontys Sales Disappoint, Affymax Headed Lower (Seeking Alpha Feb 16. 2013). It is not surprising to me that sales failed to meet expectations. The big advantage for Omontys is supposed to be the monthly dosage compared to Amgen's weekly dosage. However, that advantage is assuaged by the fact that dialysis patients generally receive weekly dialysis treatments.
3. Fresenius has been under FDA investigation for failure to adequately warn patients of the risks of medications based on its own internal studies, so it is now imperative for it to be especially careful with the new Omontys medication. See Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry (NY Times June 14, 2012).
4. Fresenius paused further rollout of Omontys pending review of its patient database. As the Fresenius letter states: “We are now working to analyze the full set of efficacy and safety profile information and feel that the current scale of our experience with use of the drug is adequate to complete this analysis.” If the Omontys pilot rollout was truly successful, there would be no rational reason whatsoever to pause or suspend further rollout pending the review. The pause of the rollout under all of the cirmcumstances is a huge red flag IMHO.
5. My experience in the health care industry in drafting and review letter like the one Fresenius sent tells me that the pause in the rollout is not "business as usual" or "good news" as the Wall Street analysts have opined.
Here is what I think:
Fresenius has its annual meetings for employees in March. I believe they will be announcing a plan to expand the use of Omantys at that time. The previous announcement was to allow them enough time to assemble the necessary data for announcement and presentation.
I talked someone very close to me in the medical side of the dialysis biz into reading these posts. She just rolled her eyes and laughed.
So, I guess my question is how do you expect Fresenius to do this differently than they have?
This is the best process for all major changes in medical procedures.
" If the Omontys pilot rollout was truly successful, there would be no rational reason whatsoever to pause or suspend further rollout pending the review."
Your brain has the size of a pea. How many lawsuits did you NOT win?
That is the point for the pause: to determine whether the rollout was or was not a success. Fresenius still has not assessed this. THEY HAVE TO ANALYZE THE DATA FIRST!
Sentiment: Strong Buy
All four of these tests passed their primary end point. Pearl study was for non-dialysis patients and were concerned with cadivascular events.
This was a severe allergic reaction in one thousandth of one percent of people taking Omontys. They didn't have a heart attack. They didn't get cancer or a brain tumor... They went in to anaphylaxic shock which you can get from peanuts, shellfish, milk, eggs, latex, xrays, advil, aleve, tylenol, antibiotics. The list goes on and on.... once again you are hanging your hopes on one thousandth of one percent... 0.012%... 3 out of 25000 and that an event like this can never be overcome.
Sentiment: Strong Buy
Fresenius - before bringing the delivering ratio to 100% of its facilities - decided to analyse the data.
Then they'll decide (next week).
All that come out after their analysys is another line on the Omonty's boxes related to "side effects".
Even more telling, for me, is the statement that you can prescribe the drug for new patients, if you feel comfortable with it. If they were that concerned with these allergic reactions, I would think that they would not allow this. It is one thing to state you can continue to use the drug in patients that have tolerated it, and another to state you can give it to patients who have never been challenged with it
As a retired health care lawyer, it is more likely that Fresenius would choose not to interfere with the doctor patient relationship insofar as those who have prescribed Omontys and are "comfortable" with it are concerned. If there was ever litigation concerning Omontys prescription and Fresenius had stopped further prescriptions, the plaintiff lawyers would have a field day about when the prescribing doctor knew or should have known about serious adverse reactions and when he should have known. That Fresenius statement is pure legal CYA for those doctors who have prescribed or who will continue prescribing Omontys pending the Fresenius final review. Moreover, Fresenius gratuitous report on allergic reactions supports the CYA.
godwinpeak, So let me get your "between the lines" ambulance chaser theory. You're speculating that Fresenius, is more concerned with not disrupting the doctor patient realationship than the actual patient safety?
And I use the word speculating mainly because of your comment "it is more likely", more likely is not....positively.
The truth is no one knows anything and both shorts and longs are nervous because the next news announcement will make or break either side. The CEO is terrible and the shareholders are in the dark until official news is released. Everyone is in a bad situation and getting frustrated waiting for some news to the point where some longs gave up and sold because there is money to be made else ware. I say buy low and hold and worse case day trade on a spike or wait for the news, set you stops if we roll past April 30th with hearing nothing and good luck.