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I was a paid subscriber from 2008 to 2011 or so. I just don't think they have a very good product. But who knows, they could go very well if all their competitors suck more.

I took a small positioned shares in AA a couple weeks ago. Not touching options. So far so good.
I think you will find that it will stop trading just on the price of aluminum. I expect we will see north of 15 with report or sooner. Just changed my strike 12 for 2016 to strike 15 for 2016.
 
Any ideas why NAVB is tanking even though they got FDA approval for Lymphoseek. That should normally send a biotech company through the roof.

Yeah, i've been following NAVB religiously, and it's now - in my opinion- one of the hottest in my portfolio. So here's the update.

The stock was on a slide down from 3 dollars about a year ago to 1.50. They had mark pykett as a ceo, they were burning 40 million per quarter with revenue from lymphoseek rising from ~600,000 for 2013 to 6 million for 2014.

So 3 weeks ago, mark pykett steps down as ceo to oversee a deal with licensing the lymphoseek platform (chained mannose sugars, which in lymphoseek were then bound to a radio isotope for tracking- it's these mannoses that bind to CD206, the mannose receptor, on macrophages) manocept to other companies for detection of rheumatoid arthritis and tuberculosis. So, mark steps down, and Mike Goldberg the hedge fund guy becomes interim CEO. He agrees to take no pay for being CEO.

So I increased my position x5 at that point, 1.41-1.48. Mike is excellent at handling the stock market as he's been a hedge fund manager at Platinum montaur. So he severs connections with platinum montaur and takes over as ceo of Navidea to prevent a conflict of interest (also be aware he is splitting his time fighting the BOD at ECTE). His first move is to put on hold the Alzheimers and Dementia drugs at NAVB because they are burning cash and right now medicare will not reimburse for these. Costs for 2014 drop like a rock- Mike estimates they will go from 40 million burn to 10 million burn for 2014, which allows lymphoseek sales to ramp up for the year and the company to focus on the manocept platform.

With only 30 million dollars in the bank and a burn rate of 40 million for the year, shorts were expecting a capital raise down in the 1.40 region, allowing them to trash the stock. That has just changed now that Mike cut costs.

So with that result, the stock starts to run up from 1.4 to 1.70. At 1.70, 3 days ago or so, news is released that the results of head and neck cancer sentinel lymph node tracking are equivalent to the already-approved breast cancer results for lymphoseek. The stock runs from 1.7 to 2.02 on those news. So essentially the FDA approval gets priced in. Today the FDA approves, and we are beset with a short attack, you can tell by the massive 1 minute sells. Most collection going on appears to be in 5000 share lots.

My thoughts: unfortunately, 2.00 gives the company a market cap of 300 million, and until they get more than a yearly 6 million revenue they will not be given credit for the science they have going. I believe they were overvalued 2 days ago at 2 dollars, and yet at 1.7 I believe they are fairly valued. I purchased 10,000 shares today between 1.72 and 1.78 to force the short squeeze.

PLUS they have a lot going in the future: Mark Pykett is trying to get a deal done to bring in licensing money for manocept- we know mike goldberg wants upfront money because of comments from a conference call, favorable over a % of the revenue stream for any licensing. That hasn't been priced in at all. Mark missed a conference company call because he was meeting with potential collaborators- I believe we see a license and some cash upfront- maybe 2-3 million? I would also expect that we see a raise in the price of lymphoseek in the next 6 months from 300 dollars to 400 per treatment- they said initially they were going for 400 dollars but started with 300 to increase adoption.

ALSO: Read the Adam Feuerstein article this morning where he quotes a short seller and uses that to send the stock down.
Biotech Stock Mailbag: Vanda, Navidea, Provectus
By Adam Feuerstein
 
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Just a word of caution with biotechs that are still going through clinical trials and through approval stages with their products. I heard from an insider (on a clinical side) that these trials are easily and often manipulated. It might pay off to read how the trials are conducted, to digest the trials reports and make your own assessment. Sound understanding of statistical analysis methods is very helpful.
 
Just a word of caution with biotechs that are still going through clinical trials and through approval stages with their products. I heard from an insider (on a clinical side) that these trials are easily and often manipulated. It might pay off to read how the trials are conducted, to digest the trials reports and make your own assessment. Sound understanding of statistical analysis methods is very helpful.

Would disagree strongly with that. Trials are not easily manipulated however biotechs are notorious for overestimating their chance of suceess. If they were easily manipulated then we would see a lot less failures.

im less of a fan of lymphoseek as the clinical utility isn't as high as a treatment (it's a diagnostic). Helpful, yes, but no anywhere as high as most newer cancer therapeutics. My question would be - what is the realistic revenue picture for the product? Especially since they have stopped investing in their other compounds.
 
Would disagree strongly with that. Trials are not easily manipulated however biotechs are notorious for overestimating their chance of suceess. If they were easily manipulated then we would see a lot less failures.

im less of a fan of lymphoseek as the clinical utility isn't as high as a treatment (it's a diagnostic). Helpful, yes, but no anywhere as high as most newer cancer therapeutics. My question would be - what is the realistic revenue picture for the product? Especially since they have stopped investing in their other compounds.

Maybe manipulated is a strong word. I could not think of a better fitting one, my bad. If one reads trial results in original, it is often more vague than summary interpretation of results. The trials are often done on a small number of people. My friend, who is involved on clinical side of the trials, claims that trials are often very difficult to conduct, there are too many challenges and results may be ambiguous.
 
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Maybe manipulated is a strong word. I could not think of a better fitting one, my bad. If one reads trial results in original, it is often more vague than summary interpretation of results. The trials are often done on a small number of people. My friend, who is involved on clinical side of the trials, claims that trials are often very difficult to conduct, there are too many challenges and results may be ambiguous.
I used to be in the clinical trials business, and I think it's fair to say that investors should carefully understand the clinical trials. Because they are done double-blind, the clinical researchers can't steer the outcomes. The fundamental design of the trial, however, may not be as good it should be. They usually target a very selective patient profile that the drug company has identified as most likely to succeed. Success in this population doesn't predict success in the broader patient population (=commercial success), but it does check the box of "safe and efficacious" with the FDA. Also be aware that, until you have a success in Phase 3, you're still betting on thin odds. Phase 2 trials are too small to learn a great deal about the drugs efficacy.
 
yep - its a tough place to invest with lots and lots of details that can mean life vs death for these companies. I've been in drug development for a couple of decades and only recently have started investing in companies. I'm way more comfortable in industrials and tech.

With that said - I am very interested in taking a position in BlueBird Bio tomorrow. They reported a simigen of data this weekend - only four patients; which is a tiny, tiny, tiny number. However they are trying to induce (via gene therapy) expression of a key blood protein in patients who were born without a functioning set of genes. These patients are required to be on lifelong blood transfusion therapy. Because we know exactly who these patients are, which protein they are missing and the likely hood of a spontaneous cure is basically non-existant, I think the data (which showed that both patients produce the functional protein and no longer need transfusions) is impressive.

Lots of questions remain however, 1. How safe is the therapy 2. What proportion of patients will it work on 3. Do/ will the responders spontaneously revert to diseased state 4. how much time/ money will it cost to get approved 5. how big is the market (it is a rare disease) ....

Reasons why I like it 1. they insert the gene into the patients stem cells, so if it works the response should be durable 2. this technology should also work in hemophilia, although they are not working on it 3. they are working in sickle cell, where this should work
 
Would disagree strongly with that. Trials are not easily manipulated however biotechs are notorious for overestimating their chance of suceess. If they were easily manipulated then we would see a lot less failures.

im less of a fan of lymphoseek as the clinical utility isn't as high as a treatment (it's a diagnostic). Helpful, yes, but no anywhere as high as most newer cancer therapeutics. My question would be - what is the realistic revenue picture for the product? Especially since they have stopped investing in their other compounds.

The revenue stream from Breast cancer- Lymphoseek is predicted to be in 2014 about 6 million, and 10 million in 2015. The addition of Head and neck approval adds the possibility for more revenue, perhaps another million.
However, these predictions don't take into account: 1 I think melanoma data looked as good as head and neck, so they should be able to get another indication there.
2) Europe. This is soon being considered in Europe, and that should double the adoption rate
3) price increase. The initial price was going to be 400 dollars, but in order to increase adoption they started with 300.
 
The revenue stream from Breast cancer- Lymphoseek is predicted to be in 2014 about 6 million, and 10 million in 2015. The addition of Head and neck approval adds the possibility for more revenue, perhaps another million.
However, these predictions don't take into account: 1 I think melanoma data looked as good as head and neck, so they should be able to get another indication there.
2) Europe. This is soon being considered in Europe, and that should double the adoption rate
3) price increase. The initial price was going to be 400 dollars, but in order to increase adoption they started with 300.

1. Sentinel lymph node excision all biopsies done it any positive than has already spread to others throughout body. Is lymphoseek more sensitive than biopsy? Doubt it would eliminate need of sentinel biopsy.
2. Melanoma if it reaches a certain depth of invasion than regional lymph node biopsy performed. Same argument.
 
1. Sentinel lymph node excision all biopsies done it any positive than has already spread to others throughout body. Is lymphoseek more sensitive than biopsy? Doubt it would eliminate need of sentinel biopsy.
2. Melanoma if it reaches a certain depth of invasion than regional lymph node biopsy performed. Same argument.

Just to be clear, are you saying that if any sentinel nodes are positive by biopsy then all sentinel nodes must be taken out? I will have to look into this, but I assumed that this was the point of lymphoseek: you didn't have to excise more than the ones that are positive by radioisotope tracer. I remember them toting it as a perk that doctors only have to remove 4-6 nodes not 38 because of lymphoseek.
 
Just to be clear, are you saying that if any sentinel nodes are positive by biopsy then all sentinel nodes must be taken out? I will have to look into this, but I assumed that this was the point of lymphoseek: you didn't have to excise more than the ones that are positive by radioisotope tracer. I remember them toting it as a perk that doctors only have to remove 4-6 nodes not 38 because of lymphoseek.
No. If sentinel node positive than assumed nodes positive at distal sites and chemotherapy needed. Breast cancer does not spread in orderly pattern of one chain to next. Once in local nodes also distal spread anywhere. The sentinel node biopsy is not done to cure but as a predictor of need for chemotherapy
 
I'm long NAVB (for now). I'm also a MD. Let me offer just a little European perspective. Here sentinel node is used routinely for breast cancer and also head n' neck (much lower volume). What is normally used is generically made nanocolloid Tc99-marked injectable substanse (cheap) sometimes with blue dye added. Lymphoseek would have to prove to be significantly better to take a market share, since it will cost substantially more. When it comes to Malignant melanoma the use of sentinel node has decreased substantially since well if you have lymph node methastasis with melanoma pretty much the prognosis is very poor either way, and usually mutilating extended lymph node resections are avoided. Eearly radical primary removal is what counts. Interestingly there has been much debate in the last year about the new and very expensive drugs for advanced MM that can prolong life for maybe 3-6 months (Ipilimumab) where there have been many questions raised about the ethically of using that much money with that little gain, from a public health perspective.
 
With gigafactories on the horizon, and now Solar City getting into manufacturing and the justification for it, I thought that the favored supplier of factory robotics might be in for a bit of positive fallout. Those pretty things on the Tesla factory floor are made by Kuka (KUKAF OTC). I still remember at the launch party of the Fremont factory, they had a big robot "dancing", and a little girl dancing in front of it. Anyway, I'm in, we'll see where it goes.

(Remember, limit orders only for pink sheet stocks!)
 
With gigafactories on the horizon, and now Solar City getting into manufacturing and the justification for it, I thought that the favored supplier of factory robotics might be in for a bit of positive fallout. Those pretty things on the Tesla factory floor are made by Kuka (KUKAF OTC). I still remember at the launch party of the Fremont factory, they had a big robot "dancing", and a little girl dancing in front of it. Anyway, I'm in, we'll see where it goes.

(Remember, limit orders only for pink sheet stocks!)

As I recall there are four main players (and have been for some time) in the robotics field and recently there has been the addition of a couple Chinese firms that may cause some price pressure on the 'big four'.
Also, Apple and Google through acquisition may be getting into the field. Your thoughts on this? I looked into this a little when TM first said they were maxing out the assembly line and was scared off by reading about all this.
 
As I recall there are four main players (and have been for some time) in the robotics field and recently there has been the addition of a couple Chinese firms that may cause some price pressure on the 'big four'.
Also, Apple and Google through acquisition may be getting into the field. Your thoughts on this? I looked into this a little when TM first said they were maxing out the assembly line and was scared off by reading about all this.

There are certainly big and new competitors, and maybe one of them will better satisfy Tesla's and Solar City's needs, but my read on Elon is that while they're solving the problem, he'll probably keep things simple and keep ordering them. So if a relatively small company suddenly doubles or triples its output, the stock should profit. Kuka is certainly a riskier investment but that allows the possibility of bigger gains.
 
In decades past, Japanese robotics maker Fanuc at times was a significant part of our portfolios, and I certainly have seen them at work in other auto manuf. sites, mostly in Japan. I'll have a talk with some of my brokers, but I suspect they remain a far more liquid way to invest in this sector than Kuka. But thanks for that tip - I'd been wondering whose robots Tesla was using.

It's interesting, though, isn't it, that an ex-Toyota plant has robots that aren't either Fanuc or Yasukawa. Or might it be that TMC installed these German ones? Difficult to believe, as that represents an awful lot of capital that was in short supply not too many quarters ago.