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OT- Every time I turn around one of my biotechs is getting slapped. I just got finished with JAV and now VPHM is in a free fall. I've been buying on the way down so they better report positive data for HCV-796. $550M cash and a $720M market cap.
AIS - I sold some shares at higher levels, but I've still got a position. I'm not worried since they just finished the secondary and they have some positive catalysts going forward. I wouldn't be surprised to see the $1.20 level.
I'll have to listen to the CC again since I didn't think it would get this positive of a reaction. What a week, all my shares in the green.
I thought Dyloject approval in the EU was expected in the 4th qtr. I don't think they said anything about that.
Great news on the manufacturing inspection. Does anyone else think that shorty has been covering since he knew about the inspection results? Looks like it should be a positive call. One of the few biotechs in which management sticks to the timelines.
I unloaded a lot of shares above $5.20 today since I figured they would try to drop it after the call tomorrow.
We all want to know whether you jumped back in or not? No posts makes me think that the boat left you at the dock.
Now up .49 for the day, can't believe the swing.
Looks like some money is moving back into pharma stocks. RPRX and JAV are showing some strength.
OT: Take a look at VPHM. $500 million in cash, cash flow positive, Phase II & III drugs, huge short position due to generic threat. Down 5% today on a analyst initiation with a neutral. They will report four week data on HCV-796, HEP C drug any day.
Mpower, I would hate to guess regarding JAV's stock price for more then the next fifteen minutes, but thats a beautiful one day chart. The stock was able to hold the gains for the last two days and move higher into todays close which shows some nice strength. Looks like the short has decided the games over, time to cover.
I guess I should work everyday instead of watching JAV's trading. Just got home from taking an ACLS renewal class and I may have to use the algorithms on myself. NICE DAY.
The second generation antisense technology is the real deal and we should get a big partnership for 301012 later in the year. ISIS releases a new positive development every month and more dollars flowing in, but the stock can't stay over the $10.00. Maybe the CC will get us moving.
I'm not doing any celebrating, but I'm also not complaining about todays trading. Could be a little buying or covering before the conference.
He has more influence on the analysts then we give credit. Someone is going to be needed to handle any buy-out offers down the road and it might be a good idea to keep reminding the analysts of that fact.
Are you back in or did you just come by to cheer us up?
<<<Perhaps this is why we languish in the 12-14 dolar range.>>>
Maybe we languish in this area since our president refuses to get the message out to the investment community. When was the last update? The only way to find out anything regarding the regulatory paths or a number of questions raised on this board is to contact JP personally.
I was hoping that I'd never find out how it feels to get raped, but I think I know first hand now. This market is brutal for biotechs.
CC on Thursday/Aug 9th to discuss the qtr. financials and give a corporate update. Maybe we'll get a surprise concerning Dyloject.
1. Why did the company chose to start with the EU/UK mkt for Dyloject instead of going US-first? What is the timetable for a possible US approval (are they running a different p-3 study)?
Voltarol is the injectable form of diclofenac marketed in EU. Problems with Voltarol include pain on injection and a slow rate of administration. No injectable form of diclofenac is approved in the US so it made sense to go after the EU market first.
JAV announced last month that they had started the second Phase III trial for Dyloject in the U.S. NDA planned for 2008, Market in U.S. 2009.
The safety of short-term use of diclofenac, which is a nonselective NSAID, has been reaffirmed in recent white papers issued in 2005 by European and U.S. regulatory agencies.
2. What is the mkt potential in EU for Dyloject? ditto for the US?
Management gave some figures during the most recent CC of over $250 million market opportunity ($75 G5 and $175 US.) Dyloject is trying to replace Toradol in the US which has received a block box warnings for gastrointestinal/ulcer risk. If Dylojects profile shows that it does not inhibit platelet function to the same degree as Toradol then it will be a big drug in the US.
JAV should also have nasal ketamine on the US market by 2009 which is also a $250 million drug.
" JAV is really short of cash on hand." - They just completed their financing in May for $39 million so I don't understand why you made this statement. If they get EU approval for Dyloject in the next few months then those sales should support the companies operations.
Most of us are drowning in JAV shares. I watch the trading some days and its clear that someone is playing games with the stock, but its easy since the only time buyers step in is when they think they can day trade the drop. We need EU approval to get the stock headed back up.
Its funny how a new analyst was upgrading JAV every day while the stock was headed higher, but they get under the covers when the stock price sinks for no reason. Was someone feeding the analysts info or the firms dollars to pump the stock and then dumped shares?
BSR- <<<This sector is so dangeroous that you better subcribe to my rag so I can navigate you through the troubled waters.>>>>
I get the opposite impression. Why buy his subscription service when the biotech field is not worth your investment dollars?
Financial services - does anyone think these big financial service companies like Bear Sterns are having to liquidate their biotech holdings and thats whats crushing the stock prices?
Thats whats so confusing. Everyone has a different opinion why the Asoprisnil studies were stopped. I think your's has to do with endometrial growth which is why the measurements were so important in the studies.
From this article it looks like the efficacy in Phase II was very similiar to Proellex.
" Asoprisnil also consistently reduced the duration and intensity of uterine bleeding and induced amenorrhea in 28% of those taking 5 mg/day 64% of those taking 10 mg/day, and 83% of those taking 25 mg/day A significant increase in hemoglobin levels occurred in all active groups by week 12.
Asoprisnil treatment completely stopped abnormal uterine bleeding such as menorrhagia and, unlike progestins, did not induce breakthrough bleeding. Amenorrhea induced by asoprisnil was fully reversible, and resumption of normal menstruation occurred within 2 8-40 days after the cessation of treatment. Doses of 10 mg/day and 25 mg/day also resulted in significant reduction in pressure symptoms compared with placebo by week 12."
http://findarticles.com/p/articles/mi_m0CYD/is_11_38/ai_102839969
The reason given for stopping the clinical studies was the abnormal uterine tissue.
http://www.forbes.com/markets/feeds/afx/2005/10/12/afx2272084.html
BSR research has basically come to the same conclusion. There is an imbalance between risk & gain due to the shorting activities and the FDA environment. 20 - 30% avg upside move vs 50 - 70% downside moves.
I just wonder how much longer the institutions will keep investing in biotech since its difficult to move their large positions.
OT-I can't figure out why anyone invests in biotech. I've got more money then sense is the only reason I do it. POZN went before the FDA and got an approvable letter based on some CV concerns which they answered. So now the FDA moves the bar and questions a chromosome assay. The FDA admits it may be more of a test issue and not a drug issue since the anomaly was not found in the three other basic chromosome assays.
I can't imagine Proellex ever gaining approval with the current regulatory environment.
Spartex, I'm feeling a little pain with POZN. Talk about getting blindsided, what the hell, chromosomal risks. I had reduced my position and hedged, but I didn't get the upside move I needed to offset some of this JAV disaster.
I read it and thought it was a non-event.
What may look like a bargain today could be a fire sale tomorrow. I don't think anyone would advise buying more of JAV if your already overweight.
Share price/market cap is starting to look pretty attractive for bargain hunters. I didn't realize that the Ketamine announcement would concern the start of a Phase III trial so I continue to be impressed with the companies clinical progress no matter what the share price is doing.
Andrewner, since Thomas is busy or probably thinks your not worth responding to I'll ask the first question.
When did a new drug start taking 3 or 4 years to development instead of the normal 12 - 15yrs. "subsequent approvals will not be difficult and the time to market will only be three to four years for a new drug"http://usinfo.state.gov/products/pubs/intelprp/cost.htm
Can someone help me with my research? Is JAV a sub-prime lender? Thanks in advance.
Androxal should be an attractive target for pharma no matter if the FDA wants QOL's of not. Best case scenario is that you buy the drug and don't need to conduct QOL's, worse case scenario is a delay in the U.S., but you still have the EU.
I'm in the belief that we have buyers, but JP wants more dollars then their offering.
Briefing.com just gave an earnings profile on AUXL, new 52 week high. YoY sales growth for their lead drug Testim (treats hypogonadism or low testosterone)is up 40% and increased market share to 19.8% . Why someone doesn't grab Androxal is amazing.
Whats it going to take to gain some investor interest? We have gotten positive data on the Proellex Phase II, Androxal Phase III, and positive histology results without any upside movement.
Is the next catalyst or non-catalyst the FDA decision regarding the regulatory pathway for Androxal?
Glad to get the Ketamine press release behind us so we can look for news on Dyloject's marketing approval. Hopefully the shorts will start covering now.
Hindsight is 40/20. None of us could have imagined the stock getting hammered like this after gaining inclusion into multiple indexes, numerous analyst recs., no negative news, etc.
You have to wonder if the retail investor is just a pawn for the big players. Some hedge fund analyzed the chart,industry, number of shares, market cap, trading volume, and realized it was an easy short for a well funded ambush. I think its covered in chapter 9 "How to pick your target" in the hedge fund bible.
OT- Spartex, you still holding JAV? What a disaster. I originally thought that management was pumping a little hard, but I got caught in the hype.
No abnormal findings were found. All the clinical findings to date have shown Proellex to be safe and effective.
I have no idea what you mean by "'novel' characterization vs existing therapies". The existing therapies suck, (Lupron). You can not use Lupron for long term treatment. Anyone interested in partnering needs to jump on.
"seeing as the conditions described happen with aeroprisnil and RU as well"
I thought dewophile stated that no positive pre-cancerous findings were found with the other progesterone receptor modulators, but bleeding issues were the primary reason for discontinuing the clinical programs. I believe the non-uniform cystic dilatation is the description of normal endometrial hyperplasia.