This paragraph, posted by kinkey boots a.k.a. terry the clown:This may be the delay :
Unless we see cures in the Ph2/3, we think immediate US filing is
unlikely, no matter what KOLs agitate FDA for. Based on our KOL
conversations, we think FDA still has a lot to learn about NTM, having
been previously hung up on TB-like “cure” endpoints. Given trial patients
are end of the line, hard to treat, cures with only 3-mo Tx are unlikely.
INSM may decide to focus initial registration on a subset of patients
based on pre-specified stratification (CF; organism) depending on data.
Comes from a source known as Stock Market Magic, The Apprentice Millionaire. You can join this elite service for the price of $1.00 per month, or you can simply log on to Amazon and purchase the book!! The book has a stunning five star review based on......one review!! And here we have Terry the Clown quoting as if this is fact and indeed the "problem" that will lead to a delay.....he continues to be way more fos than any outhouse....
In the longer term, I do not think it matters all that much because I strongly believe that a major pharma will own the pipeline by the end of the year. There are several big players facing diminished revenues as their cash stream dries. Anywhere from $40-55 a share is my hunch. Would not be surprised if some discussions have already started. If they stay the course , they will have to raise very serious dollars, and I think that the tutes would prefer to have a deeper pocketed pharma move the process forward. All depends on $$offer$$.