Seriously AK...and thanks for the good wishes on Wednesday....If ZS-9 shows compelling efficacy and is as fast acting as reported in the 28 day trial, with no fluid overload....edema....or other issues....in a real cross section of real patients, including hopefully many that have CHF and CKD issues, a good portion of which are on RAASI drugs, and had original K levels of 5.6 or above.... (and all is well by taking only10mg of ZS-9 per day for a year...I'll be VERY surprised)....
What I fully expect though for the first 200 reported on, is a hand picked cherry picked group with an average of close to 46% (as in the earlier trial) with no real history of K issues like the 46% on placebo in the trial who had normal K levels for the 28 days), with starting K levels at 5.2, and very few CKD or CHF patients.
We'll see soon enough huh?
Take some time and start reading. All of this is not really rocket science. Elevated alt readings like Soli showed in the IV trial, when not otherwise linked to liver function issues, is not a big deal and is fully manageable by most physicians. Will the FDA look at it and possibly ask question during the approval
process? Perhaps. But it should not be a big deal frankly.
Katek is a "killer"...not literally but read their side affect profile. Scary. I doubt that many physicians prescribe it
today frankly. 2 serious allergic reactions in the entire Soli group? A non event IMHO. Simply discontinue use.
Have no idea what you refer to as the "5 failures to deliver the drug have knocked us out of europe?"
Say what? You mean the five in the Soli arm that didn't get the antibioitic for logistical reasons?
Knocked us out? Don't think so....lol.... I presume that the five who didn't get the drug were
thus listed as "failures" which reflected in the over all stats which Soli still passed with some room
to spare. EMA will approve in time after the FDA approves. Again...probably in 2017.
You call being down almost 30% on a SUCCESSFUL Phase 3 trial that met all primary and secondary endpoints "could have been much worse" I presume you are kidding? Have you ever seen a Phase 3 trial that met all endpoints down 30%? I've been doing this well over 25 years and it's a first for me.......
There are NO liver tox issues with Soli nor increased heart rates....What the "F" are you talking about?.
Moxi is black box label and use can lead to severe tendon damage.
Rosettawest was agreeing with you dr yellen.. Try and calm down....
Dog brain...How friggin stupid are you anyway pal?. You go board to board all day spouting pure garbage. Cash to trading value has nothing to do with anything? Let me see now dimwit. You'd rather own a biotech that unfortunately had some disappointing trial results but also has no cash on hand, rather than the 250 million dollars that CEMP does? OK...I get it.
Man you just don't give up do you...?
I'm long now, but you really are unreal....
Do you realize you haven't been right even ONCE on the direction of this stock from the mid 40's?
AK....RLYP has run trials that included once per day...twice per day...and even lower dosages for three times a day. RLYP expects QD approval. Bigger potential issue for both drugs will be DDI. RLYP is already doing DDI studies and those results are expected in early 2016. These studies were not required by the FDA but
RLYP did them voluntarily. DDI might be included as a potential issue in initial labeling however. Physicians see DDI as more of a nuisance as opposed to altering their prescription patterns.
CEMP....Ouch today...I bought some more down around $17 today and now average $20.35 but still hurting on my buy backs after selling all at $38.50 earlier....
Hope everyone who bashed anyone who disagreed with Kiddo and this bio guru guy poster, learned from this.
You have no friends on a message board and the most active bullish daily posters often have an agenda, and it doesn't include you or me by the way!
Long now and quite happy averaging down earlier this morning in the 17's....
AK..... Could be shorts covering and booking profits in advance of the FDA decision. That would be smart.
Or...as you said AK...The FDA does not have to wait to the very last day and maybe some good news coming earlier. The scope of the label WILL be broad. Will be approved for both acute and chronic use.
10% v 14%??? Really...That's the investment thesis thus far? And the data you're citing was the hand picked cherry picked 28 day trial data? I was referring to the year study data for RLYP...lol!
Agreed. Data will tell. But let's not make a mountain out of a molehill...11% is basically one in ten. Mild means...mild. Moderate means moderate. Edema being "resolved" is not what concerns doctors. It's
getting edema in the first place. Very painful to patients and can lead to other issues.
I think what is happening stock lurker is I made some pretty good rebuys at a $26.70 average so quite pleased.... We'll see won't we?
Milwaukee....Who said this on October 2, 2015... "Try buying CEMP...if you want solid long term growth...?"
You one big liar huh? LOL....