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NFLD has contracts in place from the red cross and several other for profit blood banks for all of their expired blood. Also the going rate from paid donors is $25.00. Estimated charge is $12-1500/ unit of Polyheme. The Armed forces will likely be a big supplier of blood and buyer of polyheme if the data is good as I hope it to be.
A note to Jellybean: The study is for PH versus saline and blood.
From the contrarian advisor on IDIX
O.K. the NASDAQ today had a pretty nice day although I was hoping for a bit more volume. The real positive is that we closed above it's 50 day moving average. Given the oversold nature of the index I would lay bet that we should have a little rally here over the next couple of days. The real strength was in the index that has been hurting us so bad of late, the Russell 2000. It had a rock solid day and it was reflected in TheContrarianPortfolio as well. The SP500 continued it's consolidation and appears to be firming, especially with Oil falling over $2.00 per barrel today. Remember where resistance is, 1318 and we closed at 1315. The test is always at the top. Volume is key right now, we need a high volume up day to keep this market together, you must have courage in your convictions and have patience with your positions. Should this market break, then dump. But for now I would watch, wait and see, don't just sell because you got a couple of dollars back. Of the positions we are down on now there isn't one that I don't think that I will eventually realize a profit on.
I heard a great Contrarian poll today, the question was "do you feel confident in the US economy?" A negative response of 70% was given. WOW I thought, we just may have a rally at hand.
Now to our positions.
PLAY had a great day today. Don't get me wrong it' was the shorts getting squeezed all day long and I loved every second of it. We closed strong and they were covering after hours as well. We may see a bit more upside here put I would expect it to poop out and we'll probably see a retest of these recent lows. So, expect this to happen, don't just sell because of another down day, expect this stock to revisit it's support line again, that's a double bottom, that's when investors come in. For now though all you see are shorts covering.
QMED continues to hold support and is consolidating nicely. Down volume was a bit high today but nothing to scary.
IDIX had a nice reversal today and closed green after being in the red most of the day. The volume pattern is great, the sellers appear to be drying up and the price action using the candlesticks is perfect.
DELL I received a few emails with regard to this pick when I sent out the initial alert. Dell today held historical support and closed up. Closing up is something Dell hasn't done much of lately. Again, I added this position yesterday using on a couple of simple buy rules. 1) the stock is at historical support 2) the candlestick chart pattern indicates that there is now indecision between bulls and bears setting the stage for a trend reversal and 3) the stock must be hated.
DSTI is one of those stocks that is so volatile that it can make you very rich or poor very fast. Last night I posted the 60 minute chart to illustrate the set up for today's move. On a weekly basis it appears to be forming a cup with handle formation which is probably the best formation for a big upside move that there is. The magic number here is $15.75, if we break above that number the next stop is $16.89.
TWX we continue to build the right side of a cup formation, we need to break out above $17.59 which just so happens to be where it's 200 day moving average is.
Now that we have determined that much of the selling is probably over in IDIX and in PLAY I will be looking to add to these positons.
Robert
TheContrarianTrader
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There is very little economic recovery (which is ALL the trial attorneys care about) on a terminally ill patient. Likewise med mal on an 85 year old is extrememly rare. Most terminally ill patients will sign what ever waiver is needed if they thought they had a hope of improvement or recovery.
Polyheme is visibly is different from both saline and blood so it doesn't take a scientist to figure out who got what. Blinding while important in designing the trial in all practicality probably doesn't make to much of a difference as the end point is cut and dried in 30 day mortality. Either you are alive or you are not at 30 days. It isn't subjective like "do you sleep better or feel less itchy, less depressed after taking this pill".
I also suspect that large number of trauma centers signing up for the study in the last year despite already being deep into the phase 3 trial may be due to trauma docs talking between them selves about the product.
My real point is the fact when you add up all the institutional IRB's looking at there own internal data it bodes extremely well for the study (plus passing 4 reviews by the independent review board). I know the product works (delivers oxygen to tissues)it was the adverse reactions that was my main worry. The adverse reactions is what has done in other companies: Biopure, Hemosol and Baxter. So if the adverse reactions are nil and the SPA includes noninferiority versus blood and saline Polyheme looks like a real winner.
The stock is low due in part to all the other company roadkill that have tried unsucessfully in the past to create an artificial blood (The street likely thinks this is just another failure). Also the negative press from the WSJ, SD paper, Sen Grassley as well as numerous ethicists have put real pressure on the stock. It has in fact, held up remarkably considering all the media assault.
The phase 3 study will be done within 6 weeks and the top line data released within 4 months so we will know shortly.
At my hospital the IRB has a duty to monitor the progress of studies at our institution. While that usually may mean just blinded updates it doesn't have to be (which is still confidential). With the bad press from the WSJ I don't find it suprising that each instituion looked at its own data to make sure there wasn't a problem with Polyheme. If there was the IRB could stop the trial at its own institution. While each site didn't announce the actual results they did say no adverse reactions and we are going to continue the study. When you put them all together you have a pretty good idea about the study overall.
The IRB has a moral and legal resposibility to its institution.
In medical malpractice you can't fiddle while Rome burns.
Northfield itself has not looked at the individual universities data. But you can bet most of the individual Universities IRB and their lead investigators did after the WSJ article came out. 4 universities suspended the trial briefly and Duke, Utah, Indiana have stated "we looked at our data and have had no adverse events atributable to Polyheme and are continuing the study". I assume they must see the unblinded study besides it isn't very hard to tell who got what.
I was not saying the entire trial was unblinded. However, most if not all of the universities have looked at there own unblinded data recently and have all said...no adverse reactions we'll continue the study. One person got 20 units of Polyheme and survived (albeit paralyzed due a gunshot to the spine).
In my opinion noninferiority with this product is just about a given which will lead to approval based on the prior SPA with the FDA.
Blood substitutes are the Holy Grail of trauma care.
The army will likely demand every unit from the pilot plant for Iraq as extremity hemorrhage is a major killer there. Recruits may even be required to donate blood for the product.
I have a sizable position in NFLD. The PIII study will be done in about 6 weeks. 4 independent reviews have given the thumbs up over the past 3 years (no one else made it past a first look) . The latest controversy had many trial participants look at there own data before continuing with the study. In a round about way this unblinded the study. They can get approval by being non inferior to blood and saline.
Did anyone see CNBC On the money tonight. It aired with Dylan Radigan at 7pm EST. They had a good piece (balanced) on NFLD and the polyheme trial.
All of the recent ethicist furor, Senator Grassley mumblings and the WSJ bash article caused many in the trial (Duke, Univ of Denver, Indiana, Utah) to look at their own data in a kind of local unblinding. They all said no adverse reactions at their institutions and elected to continue the study. Phase 3 91% enrolled as of March 31st.
100 units of heparin is a very small dose. What is the time units (per hour, day etc.)in the study
Dew: Like I said before you will know about this company before me. I still didn't know until I read your entry today.
Thanks
Lane
Hi Dew: Was in Mexico sunning this past week. I have not heard of that company. I use RF probes to treat cancer so I am not sure how the thing works. The fact it isn't public by now is likely a bad thing. I will let you know if Artes ogoes public...although you will probably know before me!!!
Hi Dew: This another crazy area that I have invested in. Medconx a privatley held company makes medical connectors, many for surgical(laparoscopic devices). They have a web site Medconx.com.
Hi Terry: The hits keep coming everyday in regards to NFLD (WSJ, SEC, Senator Grassley). I just got a margin call today (which I met). If you notice Duke, Univ of Kansas, univ of Denver, univ of Utah have come out publically in support of Polyheme saying they are continuing the study. EMT's, trauma Docs say and know it works (sometimes anecdotally). It is now the only publically traded stock I own. This is eventually going to be just a big pile of money for me to pick up in the corner.
Thanks Dew (and Beachgal) for the info. I will let you know how this speculative one does. For the record I have 250k into it (100,000 shares) but I suspect they will do a 4:1 reverse split before taking it public sometime next year market willing.
I guess we shall see. I have seen the results for artefil in the forehead wrinkles as well as the lips (just look at Liz Hurley's lips)...absolutely amazing.
Wrinkles are wrinkles. Botox is actually only FDA approved for the wrinkle between your eyes. That hasn't stopped Botox from being used everywhere there is a wrinkle. This product will likely be used in that way also not just the nasolabial fold. While the cost is not insignificant is will likely be a winner due to the permanent nature of it and I think it will cut into Botox sales.
Dew: I recently invested in a non public company Artes Medical that is coming out with Artefil(a permanent wrinkle removal injection) The FDA advisory panel gave the thumbs up and the manufacturing plant in SD got the thumbs up. Final approval is any day...week. I think this will impact Botox injections. Just an FYI
I definitely know what you are saying about diversification. I am a calculated risk taker and have a good income to recover from any setbacks. When I think the odds are in my favor (like GTCB) I push the pedal a bit. Northfield is working on the holy grail of trauma a blood substiute that can be given in the field by paramedics without the need for blood typing. The blood substitute field is littered with failed products and banckrupt companies. This one is in the home stretch to the finish line.
NPSP Ouch! Hopefully no addtional studies will be needed. The problem with hypercalkcemia is lethal arrthymias.
This was a bit of a hatchet job about a prior incomplete and unrelated study. There has been 4 interim safety checks by the independent review board as well as oversight by each trauma centers IRB. So far with the study 85% done there have been no adverse reactions reported. They are only going for noninferiority to blood and saline not superiority (ala CTIC).
The stock has taken a bit of a hit because the ethicists are complaining about the means of obtaining consent (lack of informed consent) as well as Senator Grassley poking around.
Oh well when there is blood in the streets.....
My loss was less than 15k as my average cost was 1.48 and I got out at 1.38 the day after the bad news. I will definitely rebuy at some point as I think this will be a great company. I
appreciate every one's insight at this juncture. Until then go Northfield.
I have sold all (about 100k shares) But am looking to get back in when all the dust settles as I belive in the company and the technology. I am 100% now in NFLD.
I am gone from GENR at the open tomorrow. I should have listened to Dew a year ago. I am going to plow my GTCB and GENR money back into NFLD (after the dust settles in a week or so) when the senators and the ethicists go away.
This sounds totally bogus and not worthy of this board. Isn't there some penny stock board to take this to!!!
GENR interim results out for 209. They seem only OK to me. I am somewhat long but not as much as last year. this may push me to bail completely.
beach gal: it sounds like your dad has an intermittent tachy arrythmia which comes out during bodily stresses (like his infection). He may eventually develop a-fib that stays with him. There are medications to keep him in sinus rhythm and well as electocardioversion but that is for another time. If he is willing to take the risk of a bland (versus hemorrhagic) stroke he doesn't need to take coumadin. If he was in afib for only a short period of time the risk of a stroke is certainly lower. It is all about playing the odds.
There is medication to keep him in sinus rhythm. There is also RF ablation of the pathway in the right atrium which is more riskly and invasive. It would be hard outside of Florida (where there are a lot of old people and MD's with experience in the elderly) to find a MD (EP cardiologist) to do this on a 93 year old.
Please leave the read me first on GTCB. Io io why are you so cranky? You also seem to have it out for DEW. Leave him alone.
They got extract of human pituitary (brain tissue) and alot of pituitarys are required to get enough growth hormone. this is where the prions reside so getting JC is not suprising
Hi Dew: glad to see you made it to the NFLD board. The price today is definitely down. By how much I don't know. I own 2 stocks NFLD and GTCB (about $250K each). I think approval of polyheme is a slam dunk. They have had 4 independent interim looks and passed. 31 trauma centers with their own IRB panels monitoring the data at their own institution haven't pulled the study. When San Diego needed to reup another 18 months of the study they released their data (no deaths).
They are going for noninferiority against blood and saline with Polyheme being administered at the scene of an accident. 1 patient got 20 units and lived (albeit paralyzed from the initial gunshot wound). 20 litres of saline only is death (4 times your total blood volume). No risk Aids, Hep c risks or transfusion reactions like blood.
This is an easy one.
Not really. Fat embolus is usually in younger people after multiple long bone fractures from car accidents. It takes alot of fatty marrow to cause symptoms. The hip facture damages the femoral vein and a clot can develop and can break off and go to the lungs causing shortness of breath and in severe cases sudden death. Anticagulation prevents clots from propagating and new clots from forming.
In the 60's (before Joint replacemnt was developed by Charnley in South Africa)the treatment was 6-8 weeks in bed in traction. The death rate from pneumonia, pulmonary embolus and other maladies was unbelievable. Plus the fracture didn't always heal correctly. The surgery is actually a lifesaver.
No. A hemiarthroplasty is slightly more involved (longer OR time) and implies a slghtly worse fracture that could not take a screw only. It will work fine. You will be suprised how quickly they will get him up and working.
Main risk now is for a Pulmonary embolus. They will but him on low dose blood thinners to prevent this.
Your dad has osteoporosis (by definition with a hip fracture). There are drugs for it but I am not sure it is worth it as it takes years to improve the bone mineralisation
It is likely a compression screw with a side plate.
I wish him the best Dew. In general 90 year olds do well (because if they had bad CAD or COPD they wouldn't make it to 90)
I was fan because of a possible aids cure. 2/3 decline later I gave up.
answer to Quiz: D-4F from Bruin Pharma licensed to Novartis is the mirror image of ApoA-1 Milano
Why are we talking about a foreign penny stock not even in Phase 2 trials yet. Is this some sort of pump and dump?? The revenues are almost nil and futher dilutions will certainly be necessary. What Gives?????