No problem. This letter is better then the last one I got. It's a waiting game, but will pay off for the most patient onezzzzzz
Sentiment: Strong Buy
Dear Mr. Mueller,
Thank you for contacting us regarding Omontys.
The investigation into the root cause of the hypersensitivity reactions with Omontys is still ongoing.
If we can identify and address the underlying cause, the FDA has said they would work with us on appropriate next steps for the product.
We will timely communicate the next steps when appropriate.
Takeda Pharmaceutical Company
R u kidding me. I just bought a boat load more today. I hope it goes lower so I can get more. Nothing matters if there's no news out
Hang tight Tom. I've bin in affy for 7 months. Im holding about 35,000 shares. I chk the stock every few days cuz it was draining. Now we r all at the point the O will b back. Just a matter of time. It will happen. I've sat a recall for a year before and the payout is amazing.
Sentiment: Strong Buy
I'm sure O will b back but totally under takeda due to buyout. Every time I call affymax and ask them questions they say it's all under takeda. Has to mean buyout.
Here is some evidence supporting my opinion that OMONTYS will resurface:
When administered subcutaneously (under the skin), the drug works without any serious reactions. Serious reactions have only resulted from intravenous (in the vein) injections.
All three fatalities occurred in a few dialysis centers believed to be owned by the same company, Fresenius (FMS), who has a mound of safety issues filed against it. These fatalities occurred relatively soon after FDA approval.
Takeda may identify post-approval patient reactions that did not surface during the extensive trials, and then the company will need to take definitive and demonstrable steps to remedy those newly identified reactions before any discussion of OMONTYS's return. But this is a highly unlikely scenario in my opinion and experience. The trials were extensive enough to uncover any pattern of severe patient reaction (specifically allergic/anaphylactic). Since the post-approval death rate was 3 out of 25,000 patients, it seems much more likely the cause will be identified as "human error" at the dialysis site. In this case, we could anticipate the immediate return of OMONTYS, with additional warning provisions and enhanced training requirements to be implemented and enforced at dialysis sites.
Patient issues unrelated to OMONTYS may be discovered as the cause or a significant contributing cause to the severe reactions and the 3 deaths.
New patients may have been given too high an initial dose. The severe reactions uniformly arose within 30 minutes of the first dose in new patients only.
The age and/or frailty of the patient may be a significant factor.
The severely affected patients may present with cancer and CKD, for which OMONTYS should Not have been prescribed.
Patients without a diagnosis of CKD may have received OMONTYS, which is Not indicated for these patients.
There may be other dosing factors. See the current dialysis issues involving dialysis products; namely GranuFlo and NaturaLyte. These dialysis solutions cannot be ruled out.
Severe reactions may have been inadequately handled by healthcare givers, or correct procedures may not have been followed, or there could have been contamination of the drug within the facility.
At this juncture, the future of Affymax all comes down to Takeda identifying and correcting the issue(s) with OMONTYS or the actual clinical administration of the drug itself. If it is in fact "human error" or dosing errors, the fix could be as simple as further warnings, a more specific "black box" warning, and/or additional training for dialysis personnel in the potential and remedies for such hyper-reactions, though they were fairly well documented when approved by the FDA.
I want to note here that OMONTYS's fatality rates fall far below several other very popular prescription drugs that have been sustained in the market (including other ESA's). One has to go no further than watching many commercials advertising prescription drugs to hear the (extensive) cautionary provisions of side-effects and potential for death to know that there are many drugs with comparable or worse mortality statistics that have been sustained because the benefits outweigh the consequences which is a main determinant by The FDA for approving drugs.
Ur so dumb bro. Such a weirdoooo. Bk is out of the question. Affy already said that 3 months ago. Why in the f are u hear. Nobody likes u. Ur a ugly lookin fool.
Max is still holding. He's holding till news hits. He will not post here cuz of weird people n stuff. But he said he's still holding like u all should b. there's no downside at this point. The most upsetting news we can hear is a buyout for $4
Dude ther website is down cuz they recalled a product bro. Relax. This will hot money. I've seen it many times. I'm a pro
It's hard to say wuts gunna happen. Takeda has been pretty hush hush for awhile. But big things comin
Continue holding man. Don't give up. I'm here holding cuz I kno how this will end. I've done this 10+ times. Just hang tight and u will b glade. I just don't post much since there is no news out
Iv called many times due to the amount of $$$ I hav on the line. Affy will tell u it's in takedas hands and they will release information wen investigation is over. That's all they say. I will call again next week. I call every other week just to c if things change
I believe it was done a while ago. Takeda is not preparing for the next step and how they will go about it
Ya I read it. The information they gave seems vague to me. Yes there has been some deaths. But the people giving it to people I believe made some mistakes. The only news I will take serious is the news that takeda or affy releases. These shorts do a lot of things to get stocks down. I'm not selling nothing because I'm almost positive there will b buyout or omontys will come back out
GWP #$%$ already bro. Chill out and wait till takeda let's news out bro. Ur sooo annoying with all ur #$%$. Who cares man. We all kno wuts happening here. Ughhhhh u make fun message boards boring.