Successfully completed phase 1 human safety trial clinical trials dot gov NCT0135302
Study withdrawn prior to enrollment NCT01593072. (Terminated for convenience of the Government due to funding constraits)
Contrast with tekmira
Suspended Safety, Tolerability and Pharmacokinetic First in Human (FIH) Study for Intravenous (IV) TKM-100802
Condition: Ebola Virus Infection
Interventions: Drug: TKM-100802 for Injection; Drug: Placebo
Terminated Safety, Tolerability and Pharmacokinetic First in Human (FIH) Study of Intravenous (IV) TKM-100201 Infusion
Condition: Ebola Virus Infection
Interventions: Drug: TKM-100201; Drug: Placebo
Their first study was terminated due to safety/tolerability problems. Their second was suspended despite reformulation for the same reasons.
Their cholesterolemia trial was terminated due to immune response (NCT00927459). Sound familiar?
I will be interested in seeing the order. Also the interest getting calculated from the time of the breach is wrong. Interest should start at the time sales are realized. Pip would not have had the benefit of income until there was revenue. Therefore they cannot be entitled to interest on money that would not have existed.
Baliban's model incorporates a probability of success, which is is another way of saying it is speculative.
The crux on appeal is whether parsons has correctly applied the law. I have excerpted from lemore's previous comments:
In SIGA v Pharmathene, the Delaware Supreme Court found that where the parties have a Type II preliminary agreement to negotiate in good faith, and the trial judge makes a factual finding, supported by the record, that the parties would have reached an agreement but for the defendant’s bad faith negotiations, the plaintiff is entitled to recover contract expectation damages. However, they also noted that "an expectation damages award presupposes that the plaintiff can prove damages with reasonable certainty...(“It is well-settled law that ‘a recovery for lost profits will be allowed only if their loss is capable of being proved, with a reasonable degree of certainty. No recovery can be had for loss of profits which are determined to be uncertain, contingent, conjectural, or speculative.’”"
I think the degree of certainty fails on all 4 tests.
The most ridiculous part of Judge Parsons' ruling is conflating mathematical proportion, i.e. a fraction, with a mathematical probability. They can both be expressed as a percentage but they have entirely different meanings. Applying 85% probability of success to an amount the parties expected to receive ignores the 15% probability that they would receive nothing. Probability means that nothing can be determined about an outcome prior to the event's occurrence. Also probability is not based on an opinion, it is based upon a "significant" number of repeated trials and dividing the number of a certain outcome by the number of trials.
The probability approach would only be mathematically valid if enough reasonably similar circumstances could be found and the successes and failures tabulated. Even then, It would fail the tests for reasonable certainty.
Ebola contract is under DTRA (us military).Company cannot divulge anything related to the contract that isn't "material" unless authorized by the Defense Department. That's in the contract boilerplate.
Shorts don't need a "thesis". All they need is cooperation, access to algo trading platform and a sizeable account. You have to understand that the market is not transparent.The fact that there has been no phase 3 is enough to make this company attractive to short. Add to that a history of failed products on the platform. The details on etep are superfluous.
I doubt that the viral clade has any bearing on the currently selected target for AVI-7537. My research indicates that the outbreak is Zaire EBV, the same strain used to optimize AVI-7537. The V35 protein is responsible for allowing the virus to evade the host immune system, and a major factor in ebola virulence. Unless someone can confirm that the current outbreak clade of Zaire EBV does not contain the V35 protein this is nothing but chasing hoodos. Until any drug product is tested in infected humans it is impossible to predict its efficacy. What we have is the best guess based on several animal challenges and several viral protein targets. search "Discovery and Early Development of AVI-7537 and AVI-7288 for the Treatment of Ebola Virus and Marburg Virus Infections".
The statement to me suggests Tkmr has selected a different target, possibly receptor binding.
OK TKM-EBola targets the same proteins as those tested and optimized by SRPT. So it comes down to which chemistry works best, and how precise the target sequence is. TKMR chose to retain a cocktail of targets in their product, while SRPT chose the one that worked best in monkeys.
Going back through the research, it appears that 6002 was only tested at one dosage in monkeys. The predicted 50% survival dose was 27mg/kg so the challenge was done at 40 and produced 61% survival. As far as I can tell there was no attempt to characterize the dose-response curve of the PMO+ formulation. Furthermore in human safety trials it was found that the half life of 6002/6003 was only a few hours.
In contrast, TKMR dosed a cocktail containing several targets in two different dosage regimens spanning several days. Only the higher dosage produced complete survival.
The 6003 product was observed to be more potent than the 6002 product at the same dosage. I think all this points to the need for more research. It could be argued that TKMR did a better job of study design, but then they had fewer formulation options to consider.
I think the 100% survival statistic touted by TKMR, while truthful is misleading. When looking at the 6002 survival graph, the first untreated death occurs on day 7 while the first treated one occurs on day 11. Even in the subjects that died, the drug conferred a 50% survival benefit. I think given the clearance rates it is reasonable to conclude that if dosing were continued to provide better levels you would also see 100% survival.
most likely paired arb trading. Short BCRX and SRPT and buy TKMR with the proceeds of the sale. Lets hope the bias will be reversed when a bigger fish comes in to feed.
looks like the algo is at the apex. TKMR flat; SRPT, BCRX up 6-7%. Now they sell off TKMR and cover the other two.
BARDA stockpiles MCM's , not DOD. The military got into trouble vaccinating soldiers against smallpox. If EUA is granted in support of military, use of unlicensed drugs and biologics is strictly voluntary. The process involves a recommendation from the commander in chief or his designate, and an act of congress.
The major feature of ebola infection is #$%$ (diffuse intravascular coagulation). Typical treatment involves administration of plasma which contains clotting factors consumed in the process. INTERCEPT would seem to be a great adjunct. It would allow collection of plasma from local donors without risk of introducing infection (e.g. HIV) and save time otherwise needed to screen for diseases endemic in western africa. Any antibodies to EBV collected from survivors would be a bonus.
The SIGA CEO at the time was a lawyer. He made a mistake that allowed PIP to litigate the license deal in Delaware.I think It was Drapkin's intention to lead pip to believe the license agreement was good, knowing that under New York law it would not be binding. "If you represent yourself, you have a fool for a client". I think this is what caused the falling out between the Ronald and the Donald that occurred while the merger was in play. Drapkin was fired and the acting CEO (I think it was Kasten) may have simply been misguided by his counsel, or did not engage legal counsel during the license negotiation. Either way he was acting on orders from the majority shareholder. Also there had been a previous merger attempt between the two and PIP walked leaving SIGA with uncompensated merger expenses. So there may have been a vendetta.
A CT order was last filed on 6/23/14 on 7/3/14 a clinical hold was announced on the higher dosage phase of the human safety trial. It is not unusual to see CT orders in government sponsored programs. It means that the company is exempted from reporting otherwise material news. Could be good or bad.
siga's expert is to make the calculations based on pip's expert's model with modifications as directed by the judge. See the order available on pip web site under investor tab
The predicted values are collected from healthy subjects, based on height and age. If lung function remains constant in the face of growth and age, one would expect to see a drop in the percent of predicted. Same concept applies to lung volume parameters; absolute FVC goes up due to growth. I think the pressures are more meaningful because they have to do with strength more than size. But even here bigger = stronger. It would be useful to correlate the height delta with percent predicted delta for serial tests in a subject.
Under ACA millions will be paying for health care services out of pocket. For example my primary care doc wants me to come in for a lipid panel. Thats 130 for the visit, and a hundred or so for the tests. Meanwhile I found an online special on lipid profile for $19.00 including the draw. That's worth a 45 minute drive. I'm also considering a colonoscopy in Costa Rica at 950.00 versus the same procedure where I live for 2500.00. This company is positioning itself to be in the way of a major industry shift.
lets see if it can establish new support up here. I've taken profit already and will hold the runner and see where it goes.