What a great week.
Our Affy looks like it has most probably been accumulated all week on light volume.
Rockwell Med dialysis play was very good too you know.
That AMAG comparison of .2% vs Affys .02% I saw makes me very mad if AMAG is on the mkt being a worse drug and Orwin pulled O off, you see? Do some looking there.
Sentiment: Strong Buy
Feraheme® (ferumoxytol) Injection For Intravenous (IV) Use
In clinical studies, Serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of subjects. Severe adverse reactions of clinically significant hypotension have been reported in the post-marketing experience. In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects, including three patients with serious hypotensive reactions. Monitor for signs and symptoms of hypotension following each Feraheme injection.
Do you all see this! It's so upsetting! Fereheme stats are worse than OMONTYS.
Sentiment: Strong Buy
Thalidomide was released into the market in 1957 in West Germany under the label of Contergan. Primarily prescribed as a sedative or hypnotic, thalidomide also claimed to cure “anxiety, insomnia, gastritis, and tension". Afterwards it was used against nausea and to alleviate morning sickness in pregnant women. Thalidomide became an over the counter drug in Germany around 1960, and could be bought without a prescription. Shortly after the drug was sold, in Germany, between 5,000 and 7,000 infants were born with malformation of the limbs (phocomelia). Merely 40% of these children survived.
The statistic was given that “50 percent of the mothers with deformed children had taken thalidomide during the first trimester of pregnancy.” Throughout Europe, Australia, and the United States, 10,000 cases were reported of infants with phocomelia; only 50% of the 10,000 survived. Those subjected to thalidomide while in the womb experienced limb deficiencies in a way that the long limbs either were not developed or presented themselves as stumps. Other effects included: deformed eyes, hearts, alimentary, and urinary tracts, and blindness and deafness.
The negative effects of thalidomide led to the development of more structured drug regulations and control over drug use and development. Pomalidomide, a derivative of thalidomide marketed by Celgene was approved in February 2013 by the U.S. Food and Drug Administration as a treatment for relapsed and refractory multiple myeloma.
"Thalidomide was released into the market in 1957..."
Yes, but you didn't go far enough. The "see thalomid" at the end should have led you further onward, and upward. To celgene, by way of entremed unfortunately. Enmd should have retained it. At least they would have had something to give them big revenues instead of some royalties and failed drug candidates. Instead celgene got the gravy. Not having been in celgene i can't tell you if thalomid was the foundation for their success or not, but it certainly formed part of it.
Today: New warnings will appear on the tops of bottles of Extra Strength Tylenol sold in the U.S. beginning in October. The over-the-counter drug contains acetaminophen, which, taken in high doses, can lead to complications and even death.
I am familiar with Dr Fishbane and Dr Agarwal in my investigative DD analysis:
“Patients have been greatly helped by the anemia treatments that have been available for chronic kidney disease, but unfortunately the current treatments have been somewhat inconvenient, both to patients and providers,” said principal investigator Dr. Fishbane, a Professor of Medicine, in an interview. (Meaning EPO 3x per week)
“The results of this Phase 3 program for peginesatide (marketed as OMONTYS) indicate that, for the First time, there is an agent that in dialysis patients has a very consistent and clear spectrum of results that indicate excellent efficacy and safety even when administered once monthly, so that would be really important in terms of convenience of treatment. ”While the agent did have a Comparable safety profile with epoetin in patients on dialysis, there were More safety events with peginesatide than with darbepoetin among patients with chronic kidney disease (CKD) who were not on dialysis.
“The safety signal is of concern in the CKD population, but in the hemodialysis population there was no safety signal, and that's encouraging,” said Dr. Agarwal, a Professor of Medicine, who co-moderated the session during which the results were presented.
This may have been overlooked.
Dr. Fisbane's group had NO ISSUES folks.
Dr. Agarwal said.... the agent did have a Comparable safety profile with epoetin in patients on dialysis.
CKD Patients using O....must already be on dialysis.....this is required.....
My interviews with several key dialysis and nephrology experts said.....The drug had no problems when we used it......as well as, if the drug had real serious issues, statistically...the problems would have been more WIDESPREAD......all across the country....in this case we are lead to believe that the problems were only limited to a few dialysis centers, maybe two.
Other interviews: There are many drugs sold on the market that have fatality issues far worse than what was reported on OMONTYS (three)..... that are being sold....right now..... in pharmacies and treatment centers today.....I'm not sure exactly why OMONTYS was ever "voluntarily" recalled in the first place....is it possible that Amgen had something to do with this?
Also, AFFY's new management is cleaning up the balance sheet and paying off the creditors.... All Bullish signs.
The only issue stems from....1st time users.....within the 1st 30 minutes of treatment. Maybe lower doses can be given?
It really appears that with proper screening prior to treatments and then addressing the NEW patients more carefully, (following the label religiously) this could be a BIG STEP towards allowing Takeda to get OMONTYS back on the market with a..... New Updated Risk Mitigation Plan..... filed with the FDA.
Expect further updates to follow.
From the Fresenius' Chairman - Michael, on OMONTYS, your timing's impeccable. What I can tell you is that Takeda has been working with the FDA and they are just almost at the point of getting agreement with FDA on a study that will be done in our clinics. It is a DNA type of study where they're going to be trying to understand what could potentially be within the individual that had the reactions, is there something we can learn and understand there? So it's a fairly scientific approach to what we're trying to do. But they continue to work and be very active in understanding what went wrong. So that is an update for you.
EXP - The nature of the recall is to do a RCA and correct the issues before a product can be brought back. The chairman said Takeda is working on this. The timing is impeccable? Almost at the point...
Are we to expect FDA news?
More...what we are trying to do statements.....tells us collaboration....cooperation.
What I know - Each party has a HUGE VESTED interest in getting O back online.
What would then need to happen is each dialysis provider would need Medical Advisory Board approval and assurance to use this drug. People need assurances here. Takeda is working on this now. I strongly believe that experienced Nephrologists who used the drug according to the LABEL had no issues. Now as far as an inexperienced HC employee using this powerful 1x per month drug may have had complications!
I have spoken to several experts in the field and continue to do so weekly.
Some dialysis centers in pilot programs experienced none or very few if any adverse reactions. The sudden and rapid recall was a complete surprise by many! The bottom line is....a more WIDESPREAD death rate would have occurred folks, not just a few. Samples of patient cases are being reviewed starting from the autopsy and review of other drug interactions etc. of the effected parties. Analysis is ongoing.
Expect more details to follow.
I hope this is helpful you.
Hi - Please read the bottom of this message. I believe I said....More DD is being done weekly and expect more details to follow.
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Have a good weekend everyone.
Well, Exp, I agree that Takeda has work to do before the FDA will ever allow O to return. O's voluntary recall, was a FDA Class I recall since use of or exposure to the product caused serious adverse health consequences or death. ALL CLASS I RECALLS REQUIRE THE FDA TO DETERMINE THAT THE FIRM HAS CORRECTED THE OFFENDING PRODUCT or otherwise brought the offending product into compliance, i.e. made safe, before the FDA will allow the termination of the recall and the offending product to return to market. See FDA Regulatory Procedures Manual, § 7-9. Takeda must prove to the FDA that "CORRECTION HAS BEEN MADE COMMENSURATE WITH THE DEGREE OF HAZARD OF THE RECALLED PRODUCT." 46 21 C.F.R. § 7.55(a).
As I have indicated in the past, you look the facts squarely in the eye and deny their existence. Truly you took Law 101 to heart, and personify the lesson entitled "The truth is overrated!" Jim
Sentiment: Strong Buy