Techkim01.... The issue in launching a new drug where there is no competition at the moment for
an unmet medical need is to get there FIRST before the competition does. We have a seven (7) month
lead on ZS-9 in the US yet they are likely to beat us to marketing approval in Europe? They are intent
on launching ZS-9 on both continents. So you want to basically concede Europe to ZSPH? Good thinking.
Stock was up to $34 the day before earnings were released.... Now 28's??
Guess I am not alone in the disappointment re the lack of European filing progress....partner progress....and a conference call. Hope they had a good round of golf though....LOL!
We're down 5%....again....The market is currently up 225 pts...
Is there really anyone left out there that thinks the markets and the analysts liked the last earnings report and the European filing delay?? Down from $33.25 since then...
Poor you..... Falcons suck and only someone on the run would choose to live in Atlanta...You
must love 100 degree heat and humidity in the summer and freezing in the winter! Nice.
Thanks Vegas and great explanation. Looks like TTPH might be trying to hedge their bets with the gram positive approach if the gram negative focus doesn't work out as planned...
Actually bear...I think statistics will bear out (no pun intended) that the most rapid advances in the bios come right before FDA approval and then within the next few months thereafter. Most of the buyouts occur during that period as the big pharmas and bios want to have control from basically the get go as far as management...marketing...etc.
This case may well be different, as no one has a factual idea of how big the hyperkalemia market could be.
Talk of up to 3 billion worldwide yes..But we'll have to see how fast the take up on Patiromer will actually be out of the box. ML thinks total first year sales at only 16 million but a peak market potential of around 800 million worldwide. That is why it is so important to get established in Europe ahead of the competition.
It's a huge potential market. To screw up that opportunity is unforgivable IMHO...
AK... You're too young to remember this but an entity called Commodore Computer was the first to have a personal computer out on the market for the general public. Most definitely had the first mover advantage. They sold like hotcakes in the early months of personal computing. Nintendo was next.
Then a small little known entity came out called Apple Computer and the rest so they say is history.
Being a first mover in the drug space is something like your first girlfriend. Lots of fun and you learned a lot but you didn't end up marrying her did you? LOL
As I posted here at or near the time I did it, I actually added to my position on Friday at a 27.61 avg despite already holding a huge position starting from the 18s. ZSPH has gone from the 30s to the mid 60s before retracing back into the mid 50s. We went from the low 30s to approx 42 and now we're back to 29. Our market cap has gone from well above that of ZSPH to now under theirs. Management has not only been dumping stock like a hot rock but if you iimply to analyst that you're close to a European partnership deal you better darn well come through with one. There is no excuse whatsoever for not being able to file for an MMA before ZSPH.
If you put off doing the regulatory work because you thought you were going to partner with someone and they were going to do the work for you, that's your fault if it doesn't happen. This is simply an example of bad and lazy management. They better be darn ready to present at the upcoming conference both their plans to expedite European regulatory filings as well as a detailed discussion and presentation of our marketing plans.
TTPH (which I have been in and out of over the years), is due to report Phase 3 trial results this quarter
for CUTI. It's a non inferiority trial going up against levofloxacin. We are up against Moxi which I believe is superior to Levo in general, but with quite a few more "side effects"... Lead in data from TTPH reported I believe back in April was quite positive.
So my question is basically... I thought TTPH was concentrating in the gram negative space so I was
frankly surprised to see them competing in a least one area that we are. Are there others that we are
both going after or is this just the one? TIA?
OK...all we've heard is that MEMP is the golden child for the upstream MLP's (the best in the worst neighborhood), then they put out a quarter like the last one and you realize these jokers couldn't manage
their way out of a paper bag. Expenses were up when almost everyone's elses were down, and some down big. Even BBEP, the most leveraged of them all, had a very good quarter expense wise.
Face it...We need new management at ol MEMP. These idiots think that a good hedging program is going
to make everything ok and they can just continue on with their big salaries and big spending ways until oil
recovers to $110 in a few years. Their gravy train has left the station. Hate to tell them it's time to grow up and learn to manage, or get the heck out. Time is not on our side nor on anyone eles's in this mess...
Would give them a B+ on the regulatory management team and a C on everyone else. Regulatory in the US they have done a very good job to date advancing Patiromer towards FDA approval in October. But virtually ignoring the ECU marketplace when we have a seven month jump on our competition is definitelyu NOT acceptable. This talk about an European "partner", which is apparently not coming to fruition at least as far a we know, leads to the obvious question..."What is Plan B Sherlock"?
Not having European approval for possibly up to a year or more following US approval is not a great marketing strategy with a brand new drug...no patients...yet no competition either as yet. You want to come out of the box strong worldwide...establish your presence and worth of your drug....then try and distance yourself from the coming competition. I mean this is Marketing 101 gang...Not exactly rocket science.
Thus far RLYP's management seems more intent on spending their time putting together employee incentive and option plans and grants rather than filing for EU approval on time. I mean if they would quit worrying about dumping their stock the minute it is awarded, maybe they could get some productive work done..
It's great that they have their "management" team in place for the sales team, but what about the sales team itself? Who or what is it? How many reps will we have? What states will be represented? What's the average salary for each rep? Where are they coming from? How many have we hired to date? Etc.
It is quite possible that ZSPH will be marketing ZS-9 in Europe before we will even though we have a seven
month head start. Does that make any sense to anyone here?
OK...If managment alreayd knows that we're being bought out within that seven month period all will be forgiven, but hey...The stock has gone from $42 to $29 within the last year while ZSPH has gone from
the 30's t0 the mid 50's within the same period, so something is rotten in Denmark.
Believe you are citing from the ML report? Please note that the ex-US partner was supposed to be before the PDUFA date in October (see their previous report). Now we're looking at the end of the year? Sight delay
to first half of 2015 could take us all the way to June and still be technically correct. Late 2015 would have been, at the latest....December. So the MAA submission could be as late as six months later than originally
anticipated, which in the world of competing bios and first mover advantage, etc. is quite alot frankly.
I don't think investors key in huge on these "misses" but they do want accuracy, good or bad.
When you say you're going to do something by a certain time period you better do it. Loss of credibility
counts alot more than achievement in some cases. I'm frankly not too thrilled how management handled
Looks like the intended filing of an EMA/MMA has slipped from late this year...to early 2016, to now 1st half of 2016. ZSPH has indicated they are filing for EMA 2H of 2015. RLYP...No European partner as yet either, which was expected by ML as early as October, 2015. No wonder the stock is down today.
More than likely the reason for the selloff today. Think traders may have been hoping RLYP would have some good news today re getting a partner for Europe for Patiromer. Nothing new and no news means selloff.
Nothing really new in the RLYP report except possibly a few months delay in their intentions to file for
EMA approval. 275 mil cash on hand. Fully staffed. Production right on schedule. Confusing selloff
but 8.6% down in less than an hour got my attention!!
50k outright truth... I started at $18 so those early positions were more than 70 percent of my current total position. Have more than that in CEMP from the 9's. And there's also a point of fact… I did play golf today! LOL