FDA etc
I havent been reading the BB, so forgive me if this has been covered. But there has been alot of back channel emails going around discussing the relevance of us having passed the sixtieth day without hearing from the FDA.
There has been some reference to the fact that having NOT heard about a Priortiy Review on the sixtieth day is a defacto NO on the Priority Review. I have confirmed 100% that is NOT the case
The Priority Review and the Pediatric Designation are still 100% in play . I have been told definitively that communication lines between the FDA and PLI are GOOD... and they are OPEN
The takeaway is, there is dialogue. likely in the form of requriing clarification or further information... and this has been priority one for PLI
I am told that its all now in the hands of the FDA, and that either a Priority Review Designation, Standard Review Designation and / or Pediatric Designation could come any day. It could also realistically take longer..... its in the hands of the regulators.
What I have been able to gleen is that the essence of clarifications have been straightforward, and give no cause whatsoever for concern. And that key mgmt remain very confident that their applications have the merit to attaing both Priortity Review and Pediatric Designation.
WIth the ongoing and building frustration, and the continued relative underperformance and weakness in the stock. I am going to suggest that a positive outcome is NOT priced in. There is simply too much angst. I maintain this is simply a matter of WHEN not IF.... and the fortunes and momentum will shift positively almost instantaneously with the right measure of continued patience. All the ongoing hand wringing over the balance sheet is way overblown. Good options are on the table... yet that credibility is not being given... arguably for some good reason.
Having said that....one of the hard lessons i have learned, is at those times when its MOST difficult to maintain conviction, the forthcoming outcome and payback is the largest.