You're the tough guy pumper. The enforcer. But what I've discovered is that that's a mask to hide vulnerability. It's difficult to admit that we're anxious and that things haven't gone our way. That's not to say we won't prevail. I'm betting we will. But it is to say that we're disappointed as, weeks ago, I suggested we would be.
As for your timeline, it could be accurate, but I thought the same of Captain Bionerd's assessments. Your calculations regarding future short interest might be a bit too optimistic. Were I to carve out a short thesis it would be this: that the FDA is looking for an opportunity to scuttle the application and matured PROMOVI data that ran counter to that found in 201/202 might provide it. Consequently, the passage of time is friend to neither short or long position holders except where that issue of dwindling cash is concerned.
I'm not a big fan of the testosterone approach to thesis creation. That said, keep it up!
How do you like your fumb duck? In which orafice? In cityliq's mouth? Do you like it FDA style? Slow and grinding with no end in sight? Tell us more about how much you like fumb duck.
"HOW in the world, could ANY Ombudsman accept the argument that approving a completely non toxic drug for a 100% unmet need (DMD) could cause harm to public health?"
Other than the needless use of all caps it's a very good question. An answer, perhaps the best answer, is that the process is being used not for its intended purpose but as a tool to delay a decision on the application.
As stated previously, the FDA is waiting for PROMOVI data to mature because it seems that only they and I realise that the trial will be defunct once AA is granted.
No more. Captain Bionerd of the SRPT Sarepta is looking for a new navigator as arriving at approval seems to be a difficult to reach destination with no discernable timetable. Applicants must be able to overlook the agency's own "indefinite" target date.
You see, living in the real world is difficult. Illusions are a necessary distraction but inevitably lead to disappointment. And speaking of real world needs, perhaps, the good captain could tell us when our ship will make port to replenish our dwindling supplies.
The FDA is a creative bunch when it comes to destroying companies. After watching them sytematically try to destroy Amarin by changing all the sacrosanct rules governing SPA agreements; commercial protections and scientific precepts then saddle MannKind's Afrezza with a market busting label, I wondered how they were going to do us. Answer: indefinite delay. Their words not mine.
That's 2 strikes. The first firm date was enrollment. The second a calculation based on blogger speculation. Both of these were better than a Mother's Day gift but ended the same. I'm sticking with the FDA's own timetable - "indefinitely".
I do. And I'm hoping that it's Christmas in summertime come tomorrow morning.
Sorry daddy. No 20 thumbs up for realism. And hernzd is likely speaking the truth as well. Great post!
Wow! That was really creative. I haven't heard anything like that in at least the last 10 minutes on a message board. Keep it up. I know I will.
Given the national media's biased coverage in favor of Clinton and sabotaging Trump at every turn, I could see that scenario playing out. Clinton's deteriorating health results in a very public event that causes everyone to acknowledge the seriousness of the matter. Unable to get a substitute candidate in the few weeks leading up to the election, Obama convinces Americans that the best course of action would be to postpone them entirely. Remember, according to him, Trump is unfit to be president.
You see pitylick, other than the cockroaches burrowed in your ears, that's your problem and not mine. I don't care what anyone thinks. The time we live in demands independent thinking. In your case, you lack a brain which makes the independent part irrelevant.