It's green, time for your nap and snack. You've been pecking at this and all it did was rise 50% on you in a few days. Constantly playing the same message makes the readers eyes glaze over. Hope you make it to Disney soon for a change. They have real make believe stuff.
Silver, What about ZSPH, is it better, will it's system also potentially bind drugs? The black box warning seems to make others believe ZSPH zirconium may be better than RLYP polymer that requires separation from oral drug dosing of 6 hrs. ZSPH market cap is 4-5 X RLYP currently. You can still possibly make money holding on or trading RYLP, they have cash hoard. Some others here seem to like it. Best to you
It appears when the submission is finalized the clock would start - giving PDUFA date 6 months later from what I just read.
"The review clock will not begin until the applicant informs the Agency that a complete BLA
or NDA was submitted.46 After the Agency is notified of the complete application, we will
make a filing determination within the usual time.47"
46 Section 506(d)(2) of the FD&C Act provides that any time period for review of human drug applications shall not appy until the date on which the application is complete.
47 See § 314.101, CDER MAPP 6025.4, Good Review Practice: Refuse to File, available on the Internet at fda.gov
The clock starts on date of submission, even though there is time given to accept the submission (up to 75 days). So, with priority review if they would submit on March 1 for example then PDUFA would be by Sept. 1st, typically. If there is an ADCOM it could be a couple months prior to PDUFA decision.
Probably phone calls for dinner discussions about partnership or more. Merger mania is alive and well PFE courting Allergan. BTW-no need to raise cash now, look at cash on hand.
She needs to get pajamajedi out of his onezy and off the bottle take him to McDonalds to work, but he may fixate on my little pony happy meal toys and become a "brony", she can't win, poor mummy.
Mummy will take his computer and Ipod away for that, and he can't see new movie, it is too much stimuli all those creatures.
The roll up VRX bought Sprout sex triptan for $1 billion and it is only marginally efficacious. ACRX drugs work and better alternative than what is available for low market cap and flush with cash to move pipeline along (ARX-04 and Zalviso in Phase 3), for just over cash on hand with PDLI deal.
It gives some a chance to profit, if there is a discount and you can discern the data, analysts messed up on CEMP IMO, but one could say it was a concerted attack to scare small fry out of shares so they could get in and now they can pacify each other with new presentation. They probably ask each other "you buying this one now, let's go in, we loaded at 16 from some fool, now up 50 %, get in now it will go back to $30." Later even higher.
Yeah, uh huh, why don't you bring up your little buffalo and stillbung, very insightful. You all said EU would be delayed it wasn't, said wouldn't have cash to go forward, wrong again. ARX-04 is bigger, apparently.
what about the trader who said I won't buy till 14.90, brilliant!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Miss out completely.
True, I had TSRX and DRTX buyouts. This is a different animal IMO. Can you see an oral S-pak approved, how it would sell. Prabha said soli would not be reserved from cc. Making suspension for kids would be huge. Doctors writing for 5 days oral will be big.
Cubist paid big bucks for OPTR and TSRX for lower sales now. Oral soli is first macrolide in decades to deal with resistance (see CDC 2013 report for azith. resistance, also resistance growing in gono). GAIN gives 5 years peak sales exclusivity, this is huge.
He's from England (so a little off, he is a PTIE baggie full of resentment), he also called for delay on EU approval of Zalviso (which didn't occur). ARX-04 should be better application than shot.
Lurker is small fry trying to scrape up peanuts to take his kids to disney world instead of college. A lot of posts doesn't mean big positions.