Another ignorant comment. The company is working with the FDA to establish labeling, has 105 million in the bank, and a robust pipeline.
Well, the pessimistic view is that maybe they needed that financing round which netted an 86 or so million dollar 5.5% loan based on $17.11 convertible shares... and that round would have financed the pipeline.
I hope everyone feels that way so that I can load up at 1 or 2 cents and sell it much higher.
I don't think any rational insurer will do that because then they just won't get the drug, public outcry, etc.... no? It's whacked.
The FDA must approve according to guidelines. Approval is not a question.
I listened to almost the whole adcom. There were two main topics. First, some members didn't want to approve drugs as abuse-deterrent until post-marketing studies. That's ducking stupid because it means there is almost no incentive to develop these drugs. (and no one said this either -- dumb ad comm members with PHDs!) Second, some were concerned that those ways to extract naltrexone that were possible, even though they took a day, did not take a lot of effort -- just put it in (for example) Coke and let it sit for a day. Inexplicably, the person who suggested that (Tobias Gerhard, PhD, RPh) ultimately voted for everything except actual approval.
I just want to say that it does actually hydrolize in the blood, but slowly. You can see that at 5 and 15 minutes the IN concentration was higher than the oral, but that was much different compared to the generic, and it did flip at 30 minutes.
Hard to say. However we have known a fair amount about the good data of SL-401 for really years and years. There has been a slight kink with the several recurrences in the presented data that may be a cause for concern. Hard to say if a bigger dosing would help.
Probably just the regular decay that the stock usually has, maybe some (very low) profit-taking, and IBB being down.
The company always said that Category 1 and 2 standards would be met, but not (ER) Category 3 standards, for months. They turned the ER Category 3 standard into an IR standard and the ad comm into a circus.
He is talking about a news article regurgitation of the Pfizer briefing documents for their ER abuse-deterrent drug.