I saw talk yesterday that if we make it through next week the chances of a CRL are extermely low. So, I took a look at the PUDFA calender and noticed that Delcath had a Sept. 13 PUDFA date. I then went to their website to see what the FDA did. The news they released was that they received a CRL on Sept 12. So, until the FDA actually approves Otrexup there is always a chance that a CRL is issued.
Remember the psoriasis indication for Otrexup, which was ADDED as per suggestion by the FDA. Do you really think that the FDA would do that if there wasn't a very high probability of approval? Otrexup will be approved IMHO and approval may come early...
certainly possible :-( that doesn't explain the fall.
how would the stock price go down? Is anybody strongly expecting a CRL? or has some word leaked out?? something doesn't fit here unless it is purely criminal activity (leaks from fda which is very unlikely I suppose?). either way good time to practice meditation and self awareness. how we behave when adversity strikes unexpectedly!! After all this is not the end of the world unless you have invested everything into this one.
Not sure what time the reports came out but Rueters and S&P IQ came out yesterday I believe and neither were favorable. Based on empirical data any report should reflect that. Possible catalyst to the recent activity.