It can take up to 67 more days to get full blown European Commission approval. It looks like June will be a big month for Relistor. Pending European SC version approval...and hopefully the US Oral Relistor NDA filing too.
They recommended a new indication for Relistor as the subcutaneous injection and even said Relistor offers a major contribution to patient care in comparison to existing therapies. I don't think it can get any better than that. And, the stock goes down? I just gave a post on why I think it went down.
Did Relistor get the full label expansion that company filed for exactly? Or was it a more limited indication? I am just trying to guage if expectations were higher or we met every expectation for the CHMP thumbs up.
Looks like the shares were fine up to about 11:00am then despite great news the shares were squeezed down by rhe manipulators until at 2:50pm they got the price right for a big exchange of shares, probably between funds, of 220,000 shares (over 1 and 1/3 million $). Why can't the SEC do something about this?
Sentiment: Strong Buy
The company formally known as Salix plans to file the oral Relistor NDA in 2Q15.
It doesn't take a whole lot of work to find this information, just google "Oral Relistor NDA"
ca_fisherman, you are correct. My bad on that one. Thanks for pointing that out. Cheers!! But still the CHiMPs are sure taking their sweet time. Hopefully tomorrow we hear.
Can you please advise for someone which is new on this stock what is CHMP decision on Relistor and what is the story (expectation ) here ?
Thanks a lot
They said in the conference call that they were expecting approval (analyst words) in the second half of the year. The CHMP opinion needs to happen first, which should happen shortly.
I highly doubt VRX would allow Endo to BO PGNX. PGNX is tied way to heavily to SLXP/VRX. In fact, Relistor was part of the VRX/SLXP deal. So unless VRX wants to let go of PGNX, which they wont, ENDO hasn't a shot nor will they take one.
Not sure why people are talking about a CHiMPs decision on Relistor. It was clearly stated in the CC that the second half of the year is when PGNX management was expecting a decision. From todays price action I would say that the market is NOT expecting a decision tomorrow. I guess we will see.
I'm betting that label expansion gets approved. I think there is more good news to come in the next months. This summer for PGNX share holders will be rewarding, IMO.