Thanks Jay and nice to hear from you again. I will always get some thumbs down on any board I post on as there is some disgruntled nut job out there who was in Siga Tech when I was and I posted they were going to go BK (which they ultimately did) numerous times (I was long on got out at a loss), and he obviously is still #$%$ at me and follows my post board from board daily, posting thumbs down under a different alias.. Crazy people all over this world. Mental health a very serious issue today.
And yes...This is a small bio and I've been in many of them so I've seen both the good and the bad.
PCYC was a small bio. $7-$10 for quite awhile and sold out a year or so ago to ABBV for $234 shr.
Got JNJ as a major shareholder in the low 20's. Difference there was the Baker Bros. They became their major shareholder early on and they know what they're doing. Pros v amateur hour..
OK... Here's what I'd do...
Go back about a year or more and hold another "team" meeting where a longer term business plan was probably (hopefully) discussed by the Officers and BOD. Get someone who actually knows business development rather than physicians on the Board and maybe one of the brighter ones might have suggested
co development of a pill form of our one and only product, just like the BP's do every day. This is not rocket science mind you. Then co fund that effort along with the IV trials. Allocate 5 mil share secondary at around
$14 at the time and the effort is pretty much underway.
This rather than crapshoot the development of 734 on the hopes we're going to hit on the longshot of the day
with AGN and they'd send us 60 mil in the mail to fund the effort.
Again...Love the science here but management seems pretty much clueless.
I'm going to have to dissent a bit on this issue. I am a harsh critic of JO as a CEO of this company but as a human being I cannot imagine what a day like today must of been for him.
To be accused unjustly of bringing a drug to market that has killed people is not only outright
libelous (obviously made in malice and with an intent to profit therefrom), but also unconscionable as
it relates to Mr.Orwin as a human being. To go through a day like today, basically reliving the day as former CEO of Affymax, when he did find out that a drug that was approved by the FDA and was developed and marketed by his company, was in fact "killing" people. To have to relive that nightmare one more time because some nut job was perhaps trying to drive the price of a stock down is totally outrageous and unforgiveable. I hope Orwin pursues it to the fullest extent of the law.
I realize that on the PDUFA they can well ask AZN for additional data or additional trials. Was merely making the point that the CRL was based on a mfg issue apparently rather than something they have seen thus far in the data. Again...BB likely on numerous fronts IMHO but a CRL based just on clinical data...I doubt that.
Lurk....The larger firms are saying the delay is likely 6-9 mos and not a couple of years. Mfg issues that they feel are curable and the FdA did not ask for additional clinical data. This does not mean that when they have another PDUFA they will not receive multiple black boxes on use but it does mean we just go through the same waiting drill again. If we are not sold within the next 6-9 mos the drill is probably pretty irrelevant anyway as we cannot suck up another 300 mil negative cash flow year again. We need to be sold, and now.
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