Hi Kastlem, Thanks for all the information you have provided. I am impressed with your deep knowledge and depth of research. I wish you well . I too was convinvinced on the product line of NEPH and almost bought into it. My problem is that I think this stock is being manipulated by pumpers and dumpers. Not only that when any new product is about to be introduced in USA ,you usually hear about it at ASN and Kidney and Urology journals and I find that missing. I dont have any position in the stock and am a little apprehensive of this company. I would love to know which other stocks you are long on and if you are on twitter. Good luck once again
p.s. I am not on twitter, I have thought I should look into it. My husband and sons (both grown at 24 and 28) are on facebook, I may do that instead or as well. In biotechs I have PTN, YMI, recently CBAI and MSBT as another pinkie. My husband chooses in other sectors. I post more on some than others, I only post in the biotech sector as medical is my comfort zone.
Quite welcome racharsh:-) I agree, the stock has been abused horribly which is a common problem with the pinks. The MMs and hedgies have a field day with them, especially in biotechs when the FDA is slow. Until the FDA shift themselves and make a decision, the journals probably won't cover it. Since you asked: I am currently liking ANX, it is listed on the AMEX. I bought a moderate position there on Monday morning. Take a look at the volume over the week. This is due to the imminent NDA filing for ANX-530, aka vinorilbine emulsion. Vinorelbine is useful most notably in lung and breast cancer in combination (first line) with other treatments. It is an alkaloid chemotherapy drug that prevents tumorous cells from reproducing, by interfering with microtubule protiens in abnormal mitosis. The drug in its current IV form is caustic to the veins causing reaction (sometimes severe) in about one third of patients. Tissue damge results if the drug leaks out of the blood vessel. ANX's product is an emulsified version of this vinorelbine, making a consistent suspension of nano particles to protect the tissues/veins and reduce the incidence of these reactions. Vino has been in use for 20years, 15 in the US (GSK) and has been generic here for 6 years. GSK owned it till it went generic, and I believe they are trying to recover some ownership of it by changing its form to oral. While GSKs European and Singapore trials look ok, and it is approved in Europe as oral (due to its caustic effect on veins/tissues and for home use), US oral form trials seem to be having an issue with efficacy. Oral would need around twice the dose (less bioavailability than IV), cost would probably be higher (more of the drug needed per dose) and oral doses are limited by side effects also due to increased mg's. So I think ANXs emulsified form for hospital use is better and has positive potential. Being a very small company, I wonder if they get this approved (they need only prove pharmacokinetic equivalence with a re-formulation), would GSK want to buy them out? *I do NOT have info on that, just think it may be a possibility*. Carl Ichan the billionaire is a major holder. Here is their last 10Q from Nov. http://ir.adventrx.com/phoenix.zhtml?c=75414&p=irol-SECText&TEXT=aHR0cDovL2NjYm4uMTBrd2l6YXJkLmNvbS94bWwvZmlsaW5nLnhtbD9yZXBvPXRlbmsmaXBhZ2U9NjU5NjIyNiZhdHRhY2g9T04mc1hCUkw9MQ%3d%3d As of Oct 2009 the company feels it has operating expenses for 2010, which is an improvement for them. Anyway, if you do think you like it and decide buy in, try to get .30cents or lower. I am concerned their intital plan to submit an NDA for this was held up for a year by manufacturing issues. So far as I can see they sorted those out, but a company that has had one delay just may have another???
Watch for event or speculation driven spikes and pullbacks on this if you decide on it as a momentum play. Best of luck. If you have any others you think may be good, I'd appreciate hearing about them too. Thanks and Happy New Year!
p.s... downside of neph, to be fair... Delay: The OLpur MD220/H2H module had a due date of mid June for approval from FDA. The device dept has been fraught with troubles and cannot meet its own goals as outlined by the GAO audit this summer. Our pps would not have been manipulated like this if the FDA device dept was not so inefficient. So, delay could continue indefinately, or it could get approved next week - given up trying to speculate. The OlPurMD190 and 220 are approved and in use in Europe and Canada where HDF including on-line, are the standard of care. Fresenius and Gambro also market HDF equipment overseas. (The 220 is a newer version, more surface area) http://messages.finance.yahoo.com/Business_%26_Finance/Investments/Stocks_%28A_to_Z%29/Stocks_N/threadview?bn=90217&tid=25997&mid=26006 Also, Neph management does not give a hoot about the average investor and operate on essentially a PR blackout! So most of us can't stand the management despite their credentials. Anyway, that's it from me. Again, good luck to you all here:-)