Thursday's morning drop in AFFY's share price from a previous close of just under $17 share to below $12 share has been described in some Wall Street articles as "a knee jerk reaction" or "overreaction to the Fresenius notice that it was suspending further rollout of Omontys. Other published commentators described the Fresenius notice as "business as usual" "a non-event" and one even went so far as to call it "good news" inasmuch as Affymax's final contract with Fresenius must be ready to sign. IMHO nothing could further from the truth.
It is relatively easy to read between the lines to determine the issues that give rise to the Fresenius notice. It is no secret that the European PEARL study versus the American EMERALD study disclosed "inexplicable" variances between the significant serious adverse events in nondialysis patient versus dialysis patients. See Omontys Safety Still a Problem for Nondialysis Patients (Jan. 23, 2013). Also significant is the fact that Fresenius has been under FDA investigation for failure to warn its patients of medication risks. See Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry (NY Times Jun 14, 2012). Reading between the lines the Fresenius notice, IMHO, is quite significant and does not portend "business as usual" or "good news" for Affymax and its Omontys medication. That is why I added to my short position and added puts today.
too much reading between the line godwinpeak
why don't you just read the Lines?
''The vast majority of patients who are receiving the medication on an ongoing monthly basis are tolerating it well.''
''For patients on OMONTYS®, we RECOMMEND continued use of the agent as it has been providing effective anemia management.''
do you see that ''''RECOMMEND''''?
''As many of you have become quite comfortable with the medication, physicians and facilities that have been using OMONTYS® who wish to continue prescribing it for new patients may choose to do so.''
1 in 1000 got allergic reaction=0.1%, ''Most of these reactions have been mild, but a small number have been serious'', most (conservatively say 80%) of those 0.1% reactions are mild=0.1 X 80%= 0.08%
do you believe 0.08% rate of serious allergic reaction can do any harm to a breakthrough medicine that is proving to be boon for thousands of patients (and dialysis centres too- please google talkpoint affymax presentation to understand the depth)
if i am the decision maker at FMCNA (forget my long position), i would do my best to make sure this drug reaches to those who are in need of this drug and who are tolerating it well
Fresenius contract is a done deal. I won't ask you to mark my words. Its written.
0.08% are estimated mild allergic reactions
1 in 1000 got allergic reaction=0.1%, ''Most of these reactions have been mild, but a small number have been serious'', most (conservatively say 80%) of those 0.1% reactions are mild=0.1 X 80%= 0.08% patients on omontys have mild reactions
0.02% patients on omontys have serious reactions
are you guys going to kill this drug for 0.02% patients having serious reactions?
and that too, is being warned in the Prescribing Information as FDA has instructed
yes it should be used with caution
but you cant ever think of discontinuing this medication from market
I believe, Da-Vita patients will be ditching Da-Vita soon as Fresenius signs a long term contract with takeda/affymax
Affymax Mcap of 600mn$ is laughable and shorting in the next week can be deadly
good luck to all
It is to be expected that those patients tolerating Omontys well are recommended to stay on the medication. The problem is there would be no rational reason for Fresenius to suspend further rollout if Omontys was proving itself to be a better alternative to the AMGN medication. Also, the 4th Quarter sales of Omontys disappointed and came in significantly below analysts estimates. The physicians involved in renal dialysis anemia medication are a close group and if there is a problem with new medications, especially on first dose, word spreads in the medical community. For these reasons, I believe that it is wise to "read between the lines" so to speak and I maintain a short position.
People have stated that I am full of BS to contend that I shorted AFFY from $15 plus per share, and that I am a paid Basher. Nothing could be further from the truth. Here is one of my first posts to this board to put what I say in perspective.
This is all after the fact. I can do the same, making up stories after the fact to pretend that I am always ahead of everybody else. Pure BS. You forgot to mention you didnt cover your positions at 0.78. You are biggest fool I have come across these boards hoping this to go back to. 80 again.