It could be tomorrow, or it could be months. I don't know what the FDA hangup is. Rumors are a dime a dozen.
It definitely is bad news that CLPA has no funding problems for a long time. If you want to wait for the company to go out of business, you will have to wait about another two years (assuming someone else doesn't come along and invest, like MSDW is just going to let their investment disappear).
Has CLPA announced withdrawing the NDA? Nope - absolutely a bad sign. If CLPA had any idea that they couldn't turn this around they would pull the NDA and stop paying the FDA additional funds (PDUFA). Of course their fudiciary responsibilities would warrant that kind of announcement.
Has CLPA announced that they have to provide a serious amount of additional data? Nope - absolutely a bad sign, because their fudiciary responsibilities would warrant such an announcement, if there was cause.
Has CLPA announce that they have to start or reconduct another Phase III sort of test? Nope - absolutely a bad sign, because "ditto".
Does CLPA have additional FAP data if requested? - Yep. Does CLPA have additional non-FAP data that may be relevant if requested? - Yep. Does CLPA have additional studies on-going for additional data? - Yep.
Did the FDA stop the FAP study in children? - Nope. Did the FDA stop the FAP extension? - Nope. Did the FDA stop the compassionate use? - Nope. Did the FDA stop the SAP efforts? - Nope.
Let's add this up...
The FDA says the NDA is "Not Approvable". Go ahead and continue giving the drug to those 12 and 13 year old kids. Go ahead and continue giving the drug to all those other people you have on the drug. Go ahead and test the crap out of it on other people. Go ahead and give the drug to other companies so they can play with it too.
Now, why do I think that the FDA's concerns, although maybe warranted, aren't really serious concerns as to safety and efficacy.
Now, why do I think that the end is nearer than we all think.