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two species. this rule has stood the test of time. tox is two species. period. the end.
You have to be inept to not know how to do a toxicology package.
2 species in GLP setting.
Dose-ranging including very high doses.
That's it.
I'm glad you bought it at 8c, congratulations, the VWAP for the last year tells us you were lucky and your story is uncommon.
So you're saying an IND will be filed late next year? I doubt it. Still that would be the appropriate timeline if they started real studies today.
Scam = they've made a lot of money while you've lost a bunch.
Calculate how much Diwan and Seymour have extracted at your (general shareholder's) expense.
Millions.
You are holding the bag. The VWAP of NNVC for the last several years is an interesting calculation.
You nailed it. That's how it works.
Looks like a presentation.
I'm in the drug industry. The way it works is you do your experiments and file an IND. That's it. No discussion. Anyone with experience knows how it works.
Totally accurate. The FDA has had zero involvement. ZERO.
Doing a preclinical toxicity package that would enable an IND is NNVC's only step. Doing that in a QA/QC format is difficult and requires expertise. But it's not impossible... drug companies do it everyday... this is a scam, not a drug company.
Wrong again. You have to have standardized some kind of GLP supply, put that into toxicology studies, and then file an IND. They have done none of that. You can't do home-brew mock-up drug supply and show it to the FDA and expect toxicology will be done.
NNVC should set the expectation for an IND for 2012 at best.
Simplest question for management is, do you have GLP clinical supplies? If so, which drug candidate?
Medivir news today - both good and bad
http://www.medivir.se/v4/en/ir_media/pressrelease.cfm
Pretty impressive partner (JNJ).
The good news is that companies like JNJ are interested in this space. The bad news is JNJ must have looked at all competing programs before picking Medivir. They obviously passed on you know who. The other bad news is there is a new, well-capitalized player in the space. Protease inhibitors are pretty traditional and very successful types of drugs that will be stiff competition.
Medivir Signs Research & Development Collaboration on Dengue Virus
14-Feb-11 Highlights of the Collaboration:
· Collaboration with Janssen Pharmaceutica N.V. focused on dengue virus
· Both parties to contribute 50:50 resources to the research program
· Strengthens Medivir’s presence in infectious diseases and utilises strong know-how in the discovery of protease inhibitor drugs
Any opinions on what I posted?
It appears your prediction was less than accurate.
DrFeelgood Share Monday, June 30, 2008 11:28:41 PM
Re: TheDane post# 13526 Post # of 45535
Yeah. I guess it wasn't clear that I was posting my opinion.
OK, actually what I post, unless I put IMO, is not IMO, but fact.
Fact: If one chooses to believe NNVC PRs, they are neogtiating licenses.
Fact: There are now 10 products in the pipeline, each with its own potential exclusive license.
Fact: Other pharmas in pre-IND status are getting huge upfront payments for licenses to less effective drugs.
Fact: NNVC continues to prove it has the ultimate antuiviral in the truest sense of the word, it attacks viruses.
Fact: HIV results were off the charts for efficacy.
Fact: EKC results showed complete clearing of symptoms within 48 hours of administration to infected areas.
Fact: NNVC's antivirals have roughly the toxicity of water when it comes to anything but a virus.
Fact: With all the above facts, a multi-10s-of-millions-of-dollars upfront licensing payment is in the near future and certainly before the end of summer.
Fact: Take it to the bank. IMO
I found this archived NNVC website.
http://web.archive.org/web/20050713005513/www.nanoviricides.com/ppl_home.htm
What went so wrong that they predicted Phase I would have started 4 years ago and they still haven't started?
I've been doing drug development for 11 years and I can't see how you can be off by 4 years. GLP, cGMP, all of these things take a lot less time than 4 years.
What happened?
Find another company planning a pre-IND. Good luck. Find thousands of companies planning INDs. No problem.
Guess you got proven very, very wrong.
I am, for one, a short, and I thank you for reminding me how inept management is here.
I can't think of a pharmaceutical company in history that has guided to a pre-IND filing. It is just downright funny to hear that.
Don't forget Merck, Sanofi and others with vaccines.
Looks like SIGA and other groups have NNVC beaten to the punch. Considering that there will be a vaccine out sooner or later and the actual number of cases will drop dramatically, and the opportunity for a direct anti-dengue agent is being explored by others, and there are still technical hurdles and improbabilities regarding NNVC's success, I am not willing to value a hope and a prayer that they end up with a win. No greater fool theory for me.
However, I will say that if they move into phase 1, or even conduct any activities, or tell us about conducting activities that would enable that move, I'd probably cover my short.
Not yet!
portfolios aren't supposed to be exciting, they're supposed to make consistent and large returns. no portfolio should have more than 10% in any equity, etc.
fools and their money are quickly and easily parted
You are kidding yourself. This is a scam. The lack of institutional holders, the incessant newsletter "pumping" and insider selling should be clue enough. Finally, the inability to file an IND for a new drug candidate should remind you that this company is not worth the $176 million the market is currently ascribing to it. Sell it and buy bonds.
long jnj
long ilmn
long nxtm
short mnkd
short arna
short nnvc
etc
etc
it's called a portfolio. try it sometime.
The answer is called beta
I've enjoyed success shorting other stocks. But not BTX as another Cox pick has hurt me. Time will tell on both BTX and NNVC - two bona fide scams. It's been a decent bull market. My long positions have done well, most of my shorts have not. That's why it pays to be balanced on the long and short side.
I'm shorting more. Nice to see the company has made no progress towards their IND filing goals.
It's a blatant P&D.
Management doesn't appear to do anything.
I will agree that one shouldn't treat this stock too importantly. No sane investor should have more than a few % of his portfolio in any one issuer.
Not much. Rest of the portfolio is fine. Hundreds of investments. NNVC 1% of assets or something like that.
Pretty well, I am getting filled. I'd rather have it at 0.40 than 1.40 but patience is critical.
The results aren't relevant without dosage disclosed.
This is how a real company would work, to answer your question:
Day 1: biological target (intervention point) identified
Day 2-92: screening, scaffold and series selection
Day 92-272: SAR, in vitro study
Day 272: lead nomination, intensive in vitro/in vivo studies begin
Day 365: lead nomination confirmed, testing successful
Year 1, Day 1: toxicology center selection begins, CMC/further ADME, pharmacology begins
Y1, Day 60: toxicology center selected, booked for day 90
Y1, Day 90: CMC/ADME complete, toxicology begins
Y1, Day 120: Toxicology complete with no adverse findings, IND writeup begins
Y1, Day 180: IND filed
Best case, with no hiccups, 1.5 years to put a drug into the clinic. Talking $3 million easily. NNVC has never had that kind of money, and barely has it now (assumes no hiccups!). That doesn't include overhead like executives and offices. I suspect they'll never file an IND and just string as much along as they can. Pre-IND is not a stage. It really is just a state of being new to drug development. This is not that complex if you've done it a few times. cGMP, 2 species tox package, ADME optimization, all of this is super-easy to anyone who has done it before (seymour and diwan have not), or who hires any old consultant for nothing, or who has a board of directors. sad little company.
If NNVC gets something in the Lancet, I will buy 1 million shares and wear a dress.
There's a difference between short sellers and stock manipulators. It's more likely that longs are the ones manipulating...
http://www.allstocks.com/stockmessageboard/cgi-bin/ultimatebb.cgi?ubb=get_topic;f=14;t=005322;p=1
I am shorting...
Most preclinical assets have no value due to their early and risky nature. The VC community and microcap healthcare world is full of hundreds of phase I/preclinical opportunities that can be acquired for nominal equity value.
Not this company. Do you really think it's special or a transitory value established by spurious means? I'm voting on the latter until I see a CFO, a Board of Directors, a Nasdaq listing, an IND, a major institutional shareholder. Heck, I'll take just one of those. Otherwise I can buy 10 companies for the price of one. Why would I bother with NNVC?
You act like it'd be the first microcap healthcare venture to fail?
http://www.sec.gov/investor/pubs/microcapstock.htm
http://www.sec.gov/answers/pumpdump.htm
He has told me before the firm doesn't like to keep stocks below $1 in their portfolio. Those stocks generally don't trade rationally. I disagree but he is obviously the boss of his own fund. I don't think there is a difference between a $0.99 stock and a $99.00 stock. Just decimal points. Value is still measured in millions last time I checked, and $150m is $150m too much for NNVC.
Big investors like us buy the stock without covering and then 'collapse' our boxed position at the prime broker. This way we can remove the short in one day instead of giving the marketplace a clue that we're covering. But you still make a good point.
http://www.sec.gov/rss/your_money/pump_and_dump.htm
There isn't a big need for broad-spectrum antibiotics like quinolones. Not many bugs left to kill. MRSA VRE etc are small problems but largely manageable.
There are side effects but they are rare and minimal. You can point to the rhabdomyolysis in statins and say they're toxic but the reality is the toxicity is VERY minimal. Do you think statins are toxic? If NNVC was developing a cholesterol medicine you would trash Lipitor?
Picking out a rare event to support a very broad argument is a faulty application of logic. It's especially faulty if your emotions are distorting your judgment. You want NNVC to work. I get it. But to say HIV drugs are toxic is just not right.
Here is the leading HIV drug and its prescribing information:
http://www.atripla.com/pdfs/pi.pdf
Look at page 5, which describes the AE (safety) profile of the drug. The percentages and types of side effects are miniscule.
Do rare side effects occur? Yes, with all drugs. In sum are these drugs very, very safe? Yes.
Why? I know the rest of the short interest. The short community stays in touch. There are 1.6 million shares short. That means it's me, him and 200k miscellaneous shares. It is very difficult to 'locate' said shares for shorting. The "base" at 1 looks like there is just someone buying as much as he can at 1. I think it might be my friend who is covering. If not, it's some smart institution who will surely file a 13F or 13G and we'll see their identity soon.