Thanks everyone for your thoughts. I did not want to confuse in my post the prospects for ZS approval down the road which I still think is high, with eventual black box warnings on their label, (which I think is even higher!) GLTALs...
OK...The stock is up...At least for the time being. Given back 10% in mkt value in just an hour and a half and a lot more from PM. Technically it looks like crapola right now.
CRL was apparently based on some mfg issues. NOT clinical issues which is very important.. FDA didn't ask for more clinical data but time to review the data AZN had already submitted and especially the recent DDI data they just submitted very recently. Maybe they want to see the last data on their year follow on studies maturing in Dec? Who the heck knows.....
OK...New PDUFA more than likely 6-9 months from now. Bought some time for Orwin to get scripts up or sell the company but also more time just for him to just burn through cash with no results. The guy's a clown IMHO.
We had 6 mos of no competition and no results either. You science people here can figure out that if you do the same experiment over and over with no changes, and it keeps failing, should you expect a different result?
Orwin should go now to the highest bidder and get a cash offer over $25 and sell the darn company.
Tell them the buyout gives them a free sale of the drug for at least 6-9 mos with no competition. Good selling point. But every day he waits that advantage goes down. And so does our cash. And so does our value.
The right horse wrong jockey needs to get his act together and soon.
News like a CRL for a company like AZN leaks to someone. RLYP would be moving up on above avg volume. It's flat. Volume is moderate at best. To me that smirks of a postponement until their Dec follow on trial results are known and evaluated by the FDA. Just a hunch.
Just a thought...
Maybe our fearless leader should have been doing in vivo DDI studies when he first got positive in vitro binding results for any number of elements and BEFORE we first went before the FDA..
I would love it but think it is a longshot. The FDA is very stubborn once they rule. RLYP is looking for a 3hr window andnot total eliminatiion. Extended release forumula meds is an issue in the FDA's eyes, I think if we want a real chance RLYP will have to do a Phase 2 with a much larger group and an extensive list of drugs...I mean extensive! IMHO and obvioiusly I hope I'm wrong.
You folks can continue to give me red thumbs down on every post I make but what I am saying is 100% true and you know it. Plus I probably own more stock in this company than 99% of you so give me a break.
Management needs to get off their #$%$ and start acting like pros and earn the money they're being paid.Thus far it looks like amateur hour. And why did I buy TRVN in the first place? The science. Looked pretty hard to screw up, but it seems that current management is doing their utmost best to do so.
On the BB DDI issue for ZS9. From what I've read, ZSPH did limited in vitro studies (see 10k) for DDI and found that it reacted positively only to lithium. From some Docs I've spoken to on the subject, they said if lithium was the only thing that reacted positively, in vivo studies on others may not be required by the FDA for approval. Difference is we are trying to go back and undo an FDA decision on DDI. They are not. Much harder I understand to do what we're attempting to do now by gong back to the FDA to try and change a decision they made on approval.
It really is a good strategy. AZN can sit back and watch us try and develop an HK mkt here in the US and they can learn from every bad mistake we make along the way. When the timing is right they can focus on the best markets and uses and then discount and bundle their drug with others and put us on the ropes.
Bottom line...We need to sell out and fast...
This is totally perplexing. Apparently, the company has a pain killer that is as much, or even more effective, than morphine,but without many of the major side effects. That the company has the ability to convert that pain killer from IV from into pill form to hopefully replace drugs like oxycontin. But this pill form is put on the shelf and not presently funded for trials. That the funds to do this were flushed down the toilet to pursue some longshot heart drug on the hopes of a 60 mil dollar pay day from a big drug company that didn't happen because the trial dismally failed? That the company has no other apparent plan to raise the money to fund these trials other than by issuing stock at very depressed levels and/or hoping that a partner will ring the phone and offer to help develop the pill?
Man alive.The IV morphine mkt in the US is around 350 mil a year yet the pain killer pill market for drugs like oxycontin is around 750 mil a year. So we're going after the low hanging fruit while the big prize sits on a shelf? Wow.
Maybe the whole crew should have stayed in Florence so we could start all over with competent management.
Gang....There will not be a CRL. If that was hinted at all by the FDA they would have held an advisory panel first. Or, if it was past that stage AZN would have requested a postponement of the PDUFA date.
What the FDA can and could likely do is require additional follow on studies be submitted such as DDI studies or the additional safety data from the now Dec.study. They could issue a label that is more restrictive than what AZN is asking for subject to review or revision once the additional trial data is obtained and submitted.
Best bet for us longs is a BB warning re edema...a 6hr window for not doing DDI studies...
and the label statement that those on low or no sodium restrictions should not take the drug or those suffering from HTN, CKD or CHF. Lastly, that it should not be used in emergency situations as the drug works within hours, not minutes
Sensis...If FDA were acting exclusively in the best interests of "human kind" they'd do the following:
1. Fail to rule on the ZS9 NDA. Tell them not to come back until all year follow on studies are complete and data submitted, Instruct them to do extensive DDI studies as a condition of approval.
2. Have them redesign final Phase 3 trials using BP measures more in line with human experience such as High BP defined as 145/95 not 181/105? Have them design final Phase 3 trials looking for
Na retention levels after using ZS9 over a prolonged period of time and HTN measurements etc.
3. Prove via statistical and factual data and the mechanism of action that supports their claim that
ZS9 is faster acting,and why.
4. Black Box ZS9 for prolonged use over four weeks. Black Box ZS9 for causing statistically significant edema over time. Give them 6 hour window for not doing significant in vitro DDI
In the cynical world of bio investing over the years, I've come to believe that major trial or other news leaks prior to the event date. I do not believe the ZS9 PDUFA will be any different frankly. My concern has been from day one is that AZN is large and powerful and basically has the FDA in their back pocket. We are a nothing company to them as shown by what happened to us on our PDUFA date.
Looking at how the stock is trading today at least, I think my expectations are a ZS9 approval with moderate label warnings (the white areas) that the most "common" side effects of taking ZS9 have been mild to moderate incidences of edema, constipation, etc.. Probably a 3 hour window vs 6. AZN told to conduct follow on DDI studies. Those with low sodium diets or sodium restrictions should consult with their physicians before
taking ZS9 over an extended period of time. ZS9 should not be used in an emergency situation as the drug acts within hours, rather than minutes.
That's about it. Hope I am wrong obviously as I'm ultra long on RLYP.
Looks encouraging versus oxycontin in the area of opiod induced constipation etc. but showed some similar side effects such as nausea...vomiting...headaches....etc. Pill form could be a big seller if it can be shown to have major benefits over the current SOC. Wonder why we are "looking for a partner" to take this down the road to approval when it could be the biggest seller for the company in the long run??? Most cos in the antibiotic area develolp IV and pill form together. What am I missing here?
In hindsight like many of these situations, we fell in love with the story...The science...The first new method to treat a very large unmet medical condition in 35 years. The alleged potential size of the market was huge. Estimated by some of the expert pundits as close to 3 billion persons worldwide. We were first in line. Well ahead of any perceived competition. I mean what could go wrong?
Well for one...We simply dismissed and rationalized why a very large and respected worldwide pharma,
AZN, bought our competitor for a huge premium when they were many months behind us in the approval process. Said they made a big mistake. They were crazy. Someone even bigger will buy us and probably for the same or even more than AZN paid for the competition.
Had utmost faith in management and particularly J. Orwin. That was my biggest mistake. Clinically we had in vitro DDI issues and he didn't even bother to do any in vivo studies to possibly counteract those findings before going before the FDA. We got BB'd. End of story basically at that juncture. Long term funding plan for operations was/is non existent. Sale of the company apparently not actively explored either. Now debt and dilution in the present and future unless we're bought out, probably for half of what we should have been.
What did I learn? Management always trumps science...Repeat...Management always trumps science. Never forget that. I never will.
Thinks RLYP is fullly valued at current levels in anticpation of the ZS9 PDUFA..
Moved us to "equal weight". Looks like he might be thinking at least some bad news for
ZS9 coming up......
The most obvious fix at least near term is to dump Veltdisonnect and go to the direct pharma Rx like
AZN is going to do and to the big pharma for distribution of the product...No specialty pharma nonsense.
You walk into CVS with a written script and leave with Velt, all within15 minutes.