Not only that, but as of the last update they were still screening patients and had actually not yet enrolled a single patient in the trial, I.e. actually administered a dose. Maybe 36 months? I'm out.
Other than that they're even farther away from approval than this company, no.
But Firdapse is a drug that has been used for years. It's the only drug that is any good for LEMS. Hence minimal risk. And short for a P3.
Still low-priced, with several low risk near and medium term catalysts. P3 start for Firdapse in Q4--no risk. Partnering of 115--no risk. End of P3, Q3, 2017--minimal risk. Approval six months later--minimal risk. Risk of dilution--small if the licensing of 115 comes with a generous upfront payment.
Friday or Monday? If it's approved, I will likely sell my DRRX if there's a significant gap up, because DRRX is notoriously volatile and will not hold the gain. If it's not approved, I will add to my DRRX position at lower prices.
Only one adverse event considered possibly drug-related, and that event is consistent with a known reaction to testosterone.Sounds good.
Over five years ago Apple was stating unambiguously in conference calls that the FDA was telling them that their generic EpiPen did not need to be exactly the same as Mylan's. Obviously something changed.
Results of Orient Pharma's P3 expected before year end. Mentioned partnering it for a P3 in US. Durect's tablet is taken once a day and is tamper resistant. It's a $9 billion market opportunity. Of course if big pharma comes through with big cash for 928, they might not have to partner it.
August was mentioned in the Rodman presentation as the approximate end date for the trial, a little less than a year from now. Not a terribly long time for a P3. Results a month or two later. I think they would like to partner Posimir now, but currently aren't being offered sufficient upfront cash. It would be nice to see a satisfactory deal get done before the end of the trial. As for DUR 928, I just want them to wrap the two 1b trials and get the two INDs done, so that we can have some proof of concept trials at US sites as early next year as possible. I'm tired of reading summaries of companies developing NASH drugs that don't mention DRRX.
September 25, it turns out, is a Sunday. Doesn't the FDA ever look at a calendar? That probably means everyone will watch anxiously all day Friday, and it will be approved Monday morning. If it is not approved, I will be buying shares for Posimir and DUR 928 next year.
Love the way they have two presentations scheduled right when the Zalviso trial is supposed to begin. Data from the other supplemental ARX-04 trial is also due to be released at about the same time.
Isn't it reasonable to assume that Blackrock did due diligence about the European launch before buying nearly 1.4 million shares in Q2?