I think it's absolutely incredible, considering the size and reputation of AZN, that this major issue would arise to delay their approval. Obviously AZN received advice from their clinical experts, attorneys, and anyone else involved, before acquiring ZS. I realize the FDA can be a tough sell, but ZS was supposed to be a no brainer, the favored option on the market, etc. Somehow I think Berens discovered this outcome last week, and hedged his bets accordingly.
This is a huge win for RLYP, and if they do get the label removed anytime soon, you'll really see the stock fly.
Many here called the CRL...Kudos to all, this is so awesome. Now the stakes are even higher for a BO, should RLYP go that route. In the meantime, enjoy!
Level II quotes in AH are not to be trusted, IMHO. Even in trading hours, the bids and asks disappear quickly. That said, I do see several bids in the $16's, but not much at all on the ask side, in fact most of the asks are over $19 and up! Of course as I said it all means nothing until the release, and I'm thinking BB, or other negative news for ZS. However, I don't expect RLYP to trade much over $19-$19.50 tomorrow regardless, and I'll take my $5 profit and run.
The FDA is no hurry to release bad news. My guess is the longer this goes, the less of a chance there is of ZS clear approval with no restrictions, or any approval for that matter. My headache is worse now.
I don't think I can ever recall hearing about a critical FDA decision during market hours, at least since I've been trading (16 years). so I'm sure this is an AH story. But the FDA already has made their decision on ZS, so they could have released that before the market opened; I seriously doubt they're still deliberating.....Unless, the decision is to delay the decision for more information, which will increase volatility here, but won't move the needle very much.
I don't know whether to make popcorn, or go for the Zantac at this point.
Positions are established, and have been for a few days in my opinion. I have a slight concern that there are not many bids backing up the slight drop into red territory, esp. considering yesterday's tape and the new NDA to remove the label. I still say if it pops (to $18-$19) it will probably be sold or faded, and if it falls back to $13 or so, it's time to buy again, so we could end up flat from here.
SRPT's news gives the patients and investors hope. So if the FDA didn't reject the drug, it appears they're taking more time to figure out a logical way to approve the drug.
As for RLYP, I think the move in either direction will reverse intraday, regardless. Does that make sense?
Here it is.....In all honestly there's absolutely no way to tell which direction this will go tomorrow. The intraday 60 minute chart looks very positive for a move up, but we all know you can throw away the charts for this stock for now. (see #SRPT).
I know this for sure....Whichever way it goes, the stock should be extremely volatile...so even if it falls on the perception of what ZS's decision means for RLYP, it could easily head right back up, and vice versa. I have a headache!
iCPT still in play tomorrow as well. The good news is we won't be halted either way. The really good news is I think we'll be in the $18's+ after the decision; Unlike others, I'm not expecting a major SP move in either direction.
As you know, SRPT is a completely different story, it's the only drug hope for survival for young boys. It's like the FDA is trying to figure out a way to approve the experimental drug, to keep the family's hopes alive. The market is reacting positively, because there was no outright rejection, and there's still hope.
As for RLYP, I'm in the camp that says the event tomorrow for ZS won't move the needle for RLYP as much as the analysts or others say it will.
there's still hope for an approval when they finish their studies. The real reaction will come when the FDA makes their final decision, even if they ask for a new trial, which I don't think they will.
I'm thinking SRPT and ICPT will probably be halted all day Thursday, because of their do or die pdufa FDA event. There's no reason to halt RLYP, I'm also thinking it's possible there's a delay in the news dissemination on the ZS decision, since ZSPH is no longer a public company, or not. For AZN shareholders, it's probably a meh event. I bring all this up because I'm expecting SP movement on RLYP before our broker news feeds realize why the stock is moving. Or, I could be way off base on this entire post....a normal situation during a clown show.