Looking at what happened to SRPT which hit a low of $10 after their bad news from the FDA, the stock is back up over $15 now, a 50% increase for those who bought in at the bottom. PTCT could offer the same opportunity. The downside is now minimal as it is already priced in a worst-case FDA full rejection, when in fact, they can simply correct the application and refile.
Remember that Ataluren is already on sale in 12 countries and is bringing in revenues already even though its in its infancy. So downside is minimal and upside is big.
Because they didn't break the law. Clinton did and he WAS impeached.
Obama shouldn't be impeached, because he didn't break the law. He IS enabling a corrupt FDA and that is a terrible tragedy.
Still, it is an age-old Democrat trick to try to redirect the argument to how others are "worse" (whether they are or not) because you can't argue the point at hand. We need to hold each/every government accountable and not give ANY of them a free pass. Congress holds some accountability here too, as they can influence the FDA, but at the end of the day the FDA is part of the government that Obama runs.
Just like how you pretend Bush & Reagan did wrong, if that were true, we should hold them accountable. Anything they did right or wrong has nothing to do with whether what Obama is doing is right or wrong. Wrong is wrong and 2 wrongs don't make a right. Stick to the argument at hand.
I haven't seen the NDA nor the detailed reason for the FDAs rejection, just the same headlines & reports that everybody else sees, so I can't say if the company made an inadequate filing.
It is interesting that you assume the company is at fault when based on all released information, it was the FDA who was being overzealous in their rejection. Same with BMRN and SRPT.
With PTCT it doesn't get much better in terms of a PERFECT safety record. Not a good safety record, but PERFECT! Between BMRN, SRPT, and now PTCT, it makes me wonder what is wrong with the FDA. Sure you can argue that BMRN's safety profile for drisapersen was questionable, but the rejection of SRPT's eteplirsen was shocking. Now they won't even allow PTCT to file the NDA makes me think the FDA knows they can't deny the application once in the queue and their only hope to block is to never evaluate the NDA to begin with. So they trip it up on some technicality. I'm sure more will come to light in time, but right now it stinks of corruption.
While I agree that this is likely to only cause a delay because now they have to correct the application problems and re-file, it still sucks. If I were PTCT CEO I would really plan on waiting until after the election and the change in power to re-file, but that is a long time away. Patients don't deserve that kind of delay, so my commitment to my patients would force me to go ahead and refile as soon as I'm sure we have a rock-solid application.
You assume wrong. This is about holding the government accountable, regardless of who is in power. Bush had problems when he was in, and we held him accountable too. I don't understand why some people think that their party is beyond being held accountable.
If Bush was in power, or Trump, or anybody else, we STILL need to hold them accountable. We have to put our country ahead of our party!
I think your analysis is right on target and 100% accurate. The only part I think you are missing is the blatant dishonesty in the FDA. Obama's corrupt government knows no bounds on its corruption. It is so sad it is sickening. The FDAs rejection of the PTCT NDA is proof positive.
Sure PTCT can refile and reapply but that will cause a delay of at least several months.
FDA is so corrupt it's unbelievable. I can't believe they refused to file the NDA.
Simply due to the snowstorm. They have no sense of urgency to do anything at all about Eteplirsen. Just another day at the office for them. Horrible isn't it?
The FDA has already denied Eteplirsen. It blows me away that some on this board are still pretending that there will be some intervention, or that the FDA will approve without Adcom, or that Congress will step in. It won't happen. The FDA is absolutely corrupt beyond all hope. It is the government spun out of control in the very worst way. While I wish it were different, this is the situation, period.
You are dreaming. The USA is the cash cow and the FDA is the gatekeeper to that. Patients aren't crossing the border to Canada for anything right now, and they won't in the future.