Thanks. I am going to collect a small amount of shares today, probably 10,000 for future payout of $3.1 dollar. It will be put in my retirement accounts.
It is just like to buy an option, and the risk is only a few dimes for potential $3.1 dollar.
The FDA calls such approval " the breakthrough therapy designation pathway", a designation earned if preliminary clinical evidence indicates the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases.
Kirkman should go for that, not waiting any minutes!
Oncothyreon should conduct a Phase II study of Ont-10 to seek accelerated approval for Ont-10 for ovarian cancer ASAP while pushing Merck KGaA and other big pharms to either offer buyouts or partnerships.
Kirkman should just do that, if he is not too old to be active!
For one and only one reason: it (they) don't want to pay $20 or $10 a share. Since path is a easily manipulated small biotech company, these manipulators may not be required to report to SEC for the shares involved in manipulation are less than 5% of the total shares.
Just a possibility for anyone who has the means to do some investigation. But I hope it is just a one or two time events, and the price will be appreciated steadily starting from Monday!
Where confirmatory trials verify clinical benefit, FDA will generally terminate the requirement. Approval of a drug may be withdrawn or the labeled indication of the drug changed if trials fail to verify clinical benefit or do not demonstrate sufficient clinical benefit to justify the risks associated with the drug (e.g., show a significantly smaller magnitude or duration of benefit than was anticipated based on the observed effect on the surrogate).
According to FDA on "Accelerated Approval," Ont-10 has the chance of being approved within one year!
"In 2012, Congress passed the Food and Drug Administration Safety Innovations Act (FDASIA). Section 901 of FDASIA amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow the FDA to base accelerated approval for drugs for serious conditions that fill an unmet medical need on whether the drug has an effect on a surrogate or an intermediate clinical endpoint.
A surrogate endpoint used for accelerated approval is a marker - a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. Likewise, an intermediate clinical endpoint is a measure of a therapeutic effect that is considered reasonably likely to predict the clinical benefit of a drug, such as an effect on irreversible morbidity and mortality (IMM).
The FDA bases its decision on whether to accept the proposed surrogate or intermediate clinical endpoint on the scientific support for that endpoint. Studies that demonstrate a drug’s effect on a surrogate or intermediate clinical endpoint must be “adequate and well controlled” as required by the FD&C Act.
Using surrogate or intermediate clinical endpoints can save valuable time in the drug approval process. For example, instead of having to wait to learn if a drug actually extends survival for cancer patients, the FDA may approve a drug based on evidence that the drug shrinks tumors, because tumor shrinkage is considered reasonably likely to predict a real clinical benefit. In this example, an approval based upon tumor shrinkage can occur far sooner than waiting to learn whether patients actually lived longer. The drug company will still need to conduct studies to confirm that tumor shrinkage actually predicts that patients will live longer. These studies are known as phase 4 confirmatory trials."
to be continued
Yes, I don't know what kind of signal people want: tumors are shrunk, the vaccine is safe, MOA is there clear and strong, now only on low dosages.
With higher dosages, if still safe, some patients may be cured completely (not happen yet, but has that potential)
In my humble opinion, Ont-10 should be classified as "revolutionary innovation class" [don't recall exact term that SEC calls it. If that is true, we don't need Phase II or Phase III try to get Ont-10 approved!
$2.00 strike put 4632 contracts on average $ 0.20 premium expire 16 Nov. But, I would think that effort will be definitely doom, if not this morning, definitely late this afternoon.
Any one has brain would put money to buy cheap shares, anywhere below $2 today!
since most people are afraid of dilution due to potential GIA, and since GIA is non issue now, I have no reason to believe the share price will be down on the condition:
A partnership deal is near and real, which I believe AA this time judging by all the company have been doing in the last quarter and recently.
The most difficult issue in a partnership deal now is the specific terms. This is the sticky point and is the only outstanding issue I believe.
So tomorrow, the price may be down a bit but not too much (all have been factored in in reality but definitely with some psychological impact from today's release) as it is usually the case in such a similar circumstance, some ones will get lucky to pick up some cheap shares. But the trend will quickly be reserved, maybe later in the day or shortly after that.
Just saying, in the land of freedom, anything is possible, just like Fed printing money endlessly for the sake of "economic recovery," which no one could not imagine!
while we witness a major correction of Netflix stock price!
I would venture to say the company might have been waiting for a deal to be materialized but it seemed that deal might not be able to be materialized in the time window it has for this quarter.
So the deal still could happen before now and the cc, or it could happen after cc.
Netflix just does not have the money to pay. Its current financial "health" is false and cannot be sustained. It has to either raise fee for its subscribers (probably getting killed of this idea judged from its painful experience in the past) or continually increase subscribers (it's plateaued, that's why all the fussy cooperation "news" with cables, etc., and its international campaign is just a money losing venture).
Netflix has no way to go but raise money by selling stocks, massive numbers. Or maybe crazy Cramer might be willing to mortgage his mansion to buy a piece of content for Netflix if he wants to save this hopeless company.
Only if the stock price drops significantly, can anyone be interested in buying some shares to support its operation.
The statements are basically the same between cc announcement this time and the cc announcements of the past three quarterlies.
They are and will all be held on Thursday, but this time it will be held at 4:30 pm, instead of the usual 8:30am.
When an analyst asked Kirckman a question regarding how would Oncoghyron would do to further Ont-10 trials, ie, go it alone or partnership, Kirkman said the word "ongoing" consultation. But the analysts seemed to miss it and let it slip away.
Have Oncothyreon been in discussion with Merck KGaa?
From Dr. Kirkman: Okay actually two ovarian caner patients saw their tumors shrunk (one at about three months in maintenance and the other much earlier in the treatment). A number of patients whose cancers were progressing achieved stabilization at least for six months. The immunization responses were strong and as good as preclinical trail results in addition to that Ont-10 being well tolerated and safe. Dose escalation is still ongoing.