These law suits are tag along, improperly studied strike complaints
ISIS published how many have been treated, their average ages, the FH condition and the overall results. For people of this age, and with this condition (FH) the neoplasm rate does not appear to be out of sync with the total population of treated patients and their age group. With ~150 people under testing for more than one year, 1-3 turning up with some form of cancer is normal. This appears to be the FDA committee's observation which explains why they said the patients will need to be studied further, to determine if there is a link. To find no neoplasms would be naive, as they did find some in the placebo group, which proves people are prone to cancer. (duh)
To sue because the size of the treated population was too small to tell if Kynamro is or is not causing the neoplasms is moot and in bad faith. Everyone knew the patient population sizing. The conclusion that neoplasms MAY be related to Kynamro came from a committee. Had anywhere from none to 6 patients turned up with neoplasms, you still cannot conclude anything about Kynamro causing cancer. This sizing was known to investors before they invested and was not only announced, can be determined by asking the FDA. It's both published and discoverable with the freedom of information act. Suing ISIS because its patient population was too small to rule out cancer is ridiculous and that is precisely what they are saying, in part. Take that part out, they have no basis. The suits are not because Kynamro failed to meet any endpoint. Even the FDA could not conclude the ~ 3% neoplasm rate means anything at all. Squat. If the FDA could not reach a conclusion, given these data, a court can??? I beg to differ.
As to deaths from heart attack, it is published that 50%, over the age of 50, with severe FH receiving no treatment, die from heart failure. ISIS did not publish it was inserting genes to grow a new, healthy heart. Two deaths from heart attack, in these specific groups, are nothing more than proof, the patients indeed had severe FH. Nothing more. In fact, since ISIS and Kynamro are attacking the same indication (cholesterol levels) they are only following accepted scientific principles and nothing more or less. Spot on.
These law suits are a gamble that the FDA will reject ISIS request for a license and in so doing, make the suits seem to say something pertinent. Even so, if the FDA rejects, it does not make the law suits right, not even on one point I have seen in print, thus far. 150 people, older, with FH????? What should that data look like if all, and I mean, ALL, were treated with placebos? I do not think these law firms consulted experts before reaching their conclusions, rather, they think they can find experts along the way to side with them, particularly if the FDA rejects the license app. They will never win because ISIS never promised, absolutely, they would stop the indications seen in the Phase III trials. They only promised they hit the endpoints and to what effect they hit those predetermined markers. This is absurd. Is this how lawyers make their money? Virtual ambulance chasing?
All excellent points. Everytime we have a lawsuit like this America grows a little bit weaker. If ISIS comes out of this clean all of these law firms should have to reimburse all shareholders not suing who endured a loss in share price because of their thoughtless actions. t
ISIS never promised it would obtain a license, it disclaimed that it might not get a license in its safe harbor recitals. Two deaths by heart attack and one by liver failure was and is to be expected in the group sizing and 1 + year study period and the specific type of patient. Note that they all were very likely on drug therapies for 20 years prior to entering into the ISIS study. During this trial, many more should have died, so the therapies look to be very, very effective. The cancer risk does not play...ISIS could not sign all of its partnership agreements, not see the trend in its other trials, if there was any trend there. ISIS partners had all these data, they are co principles in the trials!!!. By using a statistic that is near "0", these firms make it look like they will sue no matter what, as soon as one jurisdiction refuses a license. That is simply obvious as to their true intent. Maybe a class action by the current shareholders is in order. It would certainly be novel. Ask that ever short that covered at our expense be disgorged.