100 ml reduction in FEV1 is within the range of variability due to effort. I doubt if people can even notice the change. Normal volume is ~ 3 liters so it's a 3% reduction. Seems to me they should be able to get the spirometry screen off the label. Cough and wheezing should be sufficient contraindication. Severe bronchospasm could easily be addressed by having the prescriber coach the patient in their first puff.
It is anticipated that confirmatory studies are underway at the time AA is granted. This is to fill the information gap where there is uncertainty about a drug's effectiveness. SRPT has this covered. If AA is granted, the license can be withdrawn at any time that these studies fail to demonstrate positive results.
In the case where an unverified surrogate endpoint is being considered the FDA can bring in outside experts to give their opinion on whether the surrogate is reasonably likely to predict clinical benefit. This is what was done. The question now is whether the FDA will disregard these experts.
If the company is headed for bankruptcy why cover...ever? I surmise that the stabilization of SP around a dollar is due to covering versus new long positions. Can it be that the interest costs are too high to hold onto the short position given the delta between a dollar and zero?
If nefarious naked shorting has occurred what would happen if the company did what Oxygene did yesterday, i.e. name change and new CUSIP symbol?
Or can it be that there's really a chance for a turnaround in sales? The trading pattern suggests somebody is trying really hard to buy shares without letting the price get away from them.
That's near resistance. also a triple top. Hope it holds and consolidates. Low volume for a sustainable rally. All based on technical analysis, fwiw. The major correlation with news is what impresses me. In every recent case the direction in the days and weeks before news has telegraphed the move.
Values that are in the middle 95%of a random distribution are by definition reasonably likely.
62 million price increase, 20 million for milestone. roughly 20 million to go. With the milestone deal I think an outside investor might loan the 20 million against the holdback.
anybody have last weeks count?
The numbers indicate that the big problem with sales has been that new prescriptions did not translate into refills. The obvious reason is insurance coverage. Carriers adopt the posture of medicare, i.e. that treatment must be deemed medically necessary. With nothing but a non-inferiority designation the only rationale for prescribing is needle aversion. if the claim of faster action, matching sugar rise after a meal is substantiated, it paves the way for coverage. Coupled with documented proof that IT is less likely to cause hypoglycemia, the drug will sell.
Company can't get product liability insurance without a license. This is a major barrier that is removed by Accelerated Approval. Thanks for the pitch,, it was right in my strike zone.
repackaging and relabeling. old lots will be combined to accomodate the doubled dosage. I suspect the additional doses are free, since they were sold on a per course basis.But if siga is doing the packaging, there is likely a contract change order. I recall contingent contract items for alterations due to shelf life and dosage.
Generally meta analysis is taken with a grain of salt because the populations have different selection criteria, the purpose of the study is different, tests are performed differently, etc. Taken in the context of studies with thousands of subjects the skepticism is warranted. In the case of these Afrezza studies the investigators were the same, and the intervention was the same, i.e. afrezza. The reason results were pooled in the clamp studies is that they are invasive; a continuous infusion of glucose is administered in the face of insulin administrated to maintain a constant blood glucose level. It is harder to get subjects willing to undergo this kind of study, and it carries risks that make it unethical to do so. Increasing the number of subjects increases the statistical power. Increasing the power makes it possible to distinguish treatment effects from noise in the data when the magnitude of the effect is small.
I think the author deleted it because it was not producing the desired effect.
The 3% number comes form a study in knockout mice. The median level of dystrophin in the population was 4% and the minimum was 3%. It showed that in mice, greater than 4% rescued muscle. Where the levels were 3-4%, progressive deterioration was seen. The study did not say that levels below 3% are insufficient to prolong the age at which loss of ambulation and death occur. The study suggests that low levels, below 3% might prolong the loss of ambulation, but should not be expected to cure the condition - that would require 4% on average.
The three ERV posters are online in abstract form. Search by date, monday at 12:30. ERV was superior to LEV in infections resistant to LEV.
Treatment was effective, ie. non-inferior at end of treatment, but LEV outperformed ERV by the post-treatment period.
ERV needs to be dosed longer via IV before switching to oral.