RE:RE:RE:RE:Speculating about the ProtocolMy best guess is the confidence being displayed by management indicates the harmonization process has been completed satisfactorily and the company is just waiting for the final minutes of the understanding reached about the nature of trial. Until a company receives that confirmation, they are hesitant to speak specifically about what has been agreed upon. There clearly were sticky issues to deal with but once it has been dealt with, and I think it already likely has been, then it is likely permanently resolved. What we can't yet know is exactly what that permanent resolution exactly is. It might be a very attractive solution or it may leave some open questions that will be haunting the trial all the way through. Why it took so long to get to this point may be tied to whatever Grindpoon's patent is all about. Through a third hand account, I understand Grinspoon is pumped up about Egrifta, so his patent might the reason for that. We will have to wait a little longer to find out.
qwerty22 wrote: It's hard to know. Given the Board gave this project the green light 15 months ago, given the direct clinical data was out 15 months ago. You'd think they'd OD'ed on waiting by now.
If Philip says they are working to accommodate both regulators then the two regulators mustn't be on the same page. If they have to take advise from KOLs then it can't be that obvious a solution to them. Yet at the same time all the signals from management point to one outcome. He believes the Grinspoon trial data supports a pivotal trial but he can't say what pivotal trial that is. You can say what you expect without putting words in regulators mouths. MDGL were talking about the details of their expected trial months in advance of its approval. None of it quite adds up. This endless interaction with regulators signals a tricky problem, their path to a solution from here signals ongoing issues. I hear the confidence in their words but I don't see simplicity in either what has happened so far or what is still to come. Ed Nash wanted this to be just a simple issue of waiting for minutes of a meeting to drop thru the letterbox, Philip couldn't give him that.
It seems to me Ed Nash clearly wants to be enthusiastic about this project, he's clearly thought about it in some detail, appreciates it's something different to all the rest of the NASH programs. Is he giving it any value yet? If not there has to be something holding him back. I imagine people like Ed Nash don't really need the regulators greenlighting projects for them to make their own calls. Except when it all doesn't quite add up.
None of it quite makes sense.
longterm56 wrote: While we're speculating .... exactly what are they waiting for? Are they still awaiting approval from the agencies? Waiting on a big pharma to finalize partnering deals? Waiting on analysts to get back from vacation? Waiting for patents to be confirmed? ... just what is it that was expected to happen "mid year" and is now "a couple of months"????
-LT
Bucknelly21 wrote: I think that's a good baseline, I am surprised that no one has asked them anymore about the general nash since that seems to still be on the table. And as far as being quiet till September, we all now it's pretty quiet here all the time lol