Jagan wants to be the new Maxdad. Jagan dreams he can pump and then dump on the greater fool the AFFY shares he is holding from about $1.80.
PS Anybody who remains long here is absolutely out of their minds when AFFY itself has disclosed that talks with the FDA include voluntary withdrawal of the Omontys NDA, that cash is running out and bankruptcy remains an option. There are just too many hurdles for Takeda to overcome to bring O back to market "in the near future" as AFFY says it must if AFFY is to avoid BK.
Nobody can bash a worthless penny stock like AFFY. The fundamentals do it. One can only pump and dump this kind of stock like EXP and Maxdad did four times successfully for their own benefit.
There is no binary event. It is a fiction created by Exp and Maxdad in order to pump this fundamentally worthless stock.
I agree. One has got to have no brain at all to believe Takeda would ever want to buy AFFY under the current circumstances. A real no brainer as it were.
No company ever wants to buy AFFY with all the litigation that goes along with it. The smart move is to just wait and let time take its course. AFFY goes BK and then a purchaser can acquire whatever asset AFFY may have, at a bankruptcy court approved price which forecloses any and all challenges of fairness or adequacy of consideration, and without the headaches and litigation liabilities inherent in AFFY' securiities class action/products liabilities claims.
The Fresenius rollout was designed to replace Epogen patients with Omontys as did the EMERALD/PEARL studies. One of the criticisms of the O clinical trials was that no Epo naive patients were treated. Consequently, it would not surprise me if all of the Fresenius adverse incident reports show Epogen/Omontys as medications administered. And of course, the vast majority of O anaphylaxis deaths/SAEs have happened on the first dose of O.
That's right. Blame the nurses and dialysis centers and not O. Kind of reminds me of Maxdad when he stated that nurses should go to jail for O deaths. Recall the PEARL studies, and O's rate of "sudden death", among other disasters insofar as patient safety is concerned. Here are the PEARL statistics:
Sudden death - 2.1% O, 0.3% Epo [O 7x more]
Death from unknown cause- 2.4% O, 1.2% Epo [O 2x more]
Unstable angina - 2.4% O, 0.9% Epo [O 2.6x more]
Arrythmia - 5.6% O, 4.0% Epo [O 1.4x more]
Acute Renal Failure - 8.5% O, 4.3% Epo [O 2x more]
Convulsions - 1.2% O, 0.3% [O 4x more]
Treatment Failure - 3.5% O, 1.5% Epo [O 2.3x more]
Another Jagan pumper lullaby (or should I say outright lie?): "The reaction is First day & first time reaction only. There are no subsequent reactions witness with all of the 25000 patients treated."
Truth: From the FDA patient case narratives:
"Patient received Omontys 15 mg IVP…this was patient's second dose, the first dose was Omontys 10 mg IVP given on 1/21/13…Patient was unresponsive with no pulse."
"The patient had no known allergies…At 11:44 am, the patient received her second dose of Omontys. At 12:23 pm, the nurse was called because the patient's blood pressure was 73/28 mmHg and her heart rate was 41 bpm. The patient was found to be unresponsive with no pulse and she was apneic."
While Jagan's first point above is patently false, his second point about the European ongoing Omontys trial "for a specific ailment" neglects to mention the ailment treated and the test size. The ailment now being treated by Omontys is Europe is pure red cell asplasia (PRCA), a very rare reaction from patients who develop non-neutralizing antibodies to the recombinant human erythropoietin (Epo). Because O is an unnatural substance unrelated to Epo, those patients who have developed Epo antibodies leading to PRCA do not create antibodies to O and O can be used to treat their anemia. Because PRCA is so rare, the test size is just six patients and Takeda's decision to supply these patients with O is viewed as a humanitarian gesture.
Jagan's third point of just 3 O patient deaths has been refuted and proven wrong time and again. In fact, the FDA FAERS reports 22 patient deaths related to O. The Wall Street Journal, in a FOIA request made immediately after O's recall, discovered 12 O patient deaths.
The present AFFY longs are stuck and would like nothing better than another pump and dump. AFFY is not a buy and hold kind of speculation. AFFY is likely to go BK.
Hardly. Look at the notes of the review committee. They are nearly verbatim of the criticisms of the EMA concerning Takeda's MAA for Omontys. Actual patient usage proved the FDA's lone dissenting critic to be correct. The reality was that the FDA held its nose and approved Omontys in order to have an alternative to Amgen ESAs. They only approved O because the FDA was willing to experiment O administration in a controlled clinical environment that dialysis centers offered in the hopes O would prove safe. O proved itself not safe and now the FDA has egg on its face. Go ahead AFFY longs buy some more Laffystock.
Just keep ignoring what has already been disclosed AFFY longs.
There is still money for AFFY control persons to pay themselves. While AFFY certainly could file for BK at any time, it looks as if managment wants to pay itself as much as it can before the irrevovable decision to liquidate is made.
There is something new. The report is scathing insofar as Takeda's clinical studies methodology underlying the PEARL/EMERALD studies is concerned. The FDA had similar concerns in its Committe Review Report prior to Omontys withdrawal from the market due to patient deaths and SAEs. It may very well be that the FDA will require Takeda to undertake a time consuming costly new clinical study if O is ever to return. But of course, you are in denial as to what these kind of reports/criticisms most likely portend.
Nothing new here for you riv, but newbies should take note and would be well advised to read the report for themselves before throwing away their money on AFFY stock.
AFFY says it has only enough cash maybe to last to the end of the 2ndQ of 2014. Also, you are forgetting about AFFY's ruinous litigation whose claimants, should they prevail and which is likely IMHO, are paid prior to shareholders. Only in your wildest dreams is AFFY ever an $8 stock.