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.
Still, you gotta admit, a lot of the time, these reactions are not based on any fundamentals.
As usual this is wrong. The FDA cannot reveal communications because it is confidential, not directly because of IP
I did and others agreed. It might mean the FDA is really thinking more about how the label should look like. Kind of like SRPT..... had a 25% day or so because of that delay.
Gotta wait to the 9th. In my opinion the most likely outcome is that the FDA will ask for another trial that focuses on High for a complete label.
Let me see if this posts.
Hi. This is Ashley Ryu on for Randall. Thanks for taking the question. So I guess just to start, will you still launch the product if you don’t get the label but the product is approved just given how generalized genericized the market is? And can you also provide some examples of when the FDA maybe went against the AdCom’s recommendation that you think might be a good comp for this situation with Apadaz? Thanks.
Travis C. Mickle
Sure. I think in the first situation, we don’t know enough yet about what the potential label would look like. If it’s no different than Norco, I can tell all the listeners very honestly I see no value moving that product ahead. But if there are potential studies in paths that we think are low risk and can be negotiated with the agency, then that could be certainly tempered or differentiated at that point. What was the second question that you had?
I wrote a detailed reply but this yahoo #$%$ isn't working correctly today.
Maybe this will work: pastebinDOTcom/bqfkfLMb
(Replace "DOT" with ".".)
Put it into a search and you will find it. If I place a link it will probably be removed.
Seems pretty relevant for ATHX.