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They're no Morgan Stanley...
NNVC does not have any products in development, period.
Most institutional investors consider the development period to begin with IND-enabling studies. Non-GLP, non-peer reviewed studies does not constitute development. We're talking about the bare minimum drug development requirements here, and they cannot meet them. At least the funding excuse has no merit anymore. Heck, this company can't even call the FDA to schedule a meeting.
A CFO, a board of directors, both inexpensive, would be a useful step in securing the capital required to manufacture cGMP-compliant drugs.
Tamiflu goes generic soon. Roche isn't exactly worried about a preclinical company eating their already gone lunch 5 years from now.
There is a post here that demonstrates Diwan has been trying to raise money for Nanoviricides since the 80s, albeit in its different forms (Allexcel, Theracour, etc). Different name, same con game.
Diwan and company have been trying to raise institutional money for a LONG time. The lack of one solid institutional shareholder is alarming.
This (the recent Gates investment) is a real company that has attracted investment from real parties.
To date Nanoviricides still has not identified an institutional investor that has invested a sizeable amount in the company. No institutional shareholders have purchased Nanoviricides as per their 13F holdings.
The FDA requires GLP-run toxicology studies to allow for an IND filing. Generally speaking, and especially for non-life-threatening diseases where there are other therapies, at least 2 animal species have to be tested in chronic and acute toxicity studies. The cost and length of these studies is minor. So it begs the question why NNVC hasn't ran GLP-compliant toxicity studies since they are a gating factor in IND filings.
cGMP manufacturing would follow the solution of GLP compliant drug supply.
The way I see it, NNVC will be preclinical forever at this rate.
In my experience it is very difficult to determine intraday and intraweek price actions for microcap stocks. With less than $1 million trading daily, any one big buyer or seller influences the price well beyond any predictable power.
Did you read the link I sent regarding the size of proteins?
All drugs can be measured on the nano level. It is silly to think that Nanoviricides are the only drugs that operate on the "nano" scale. Almost all proteins are measured in nanometers. There are a lot of protein-based drugs. Most small molecule drugs are a tad smaller than that but you can represent them in 500pM or 0.5nM. So the idea of nanomedicine is ridiculous since it's been practiced since the 1980s with insulin, EPO, HGH, etc. Many small molecules (>10 molecules which would include Lipitor, etc are over 1nM).
http://physicsweb.phy.uic.edu/450/MARKO/N003.html
and countless more references.
It sounds like the 4 drugs are nearing the start of preclinical testing. If they haven't done toxicity yet then they are at the start, not the end.
Seems like you didn't read my post?
Pfiser is correctly spelled Pfizer.
Proteins are much too small to be seen in an optical microscope - a characteristic protein size varies from about 3 to 10 nanometers (nm).
I've spent a lot of time looking at proteins... nanometers is the right range. The very idea they would name the company nanoviricides tells you something is wrong. There is nothing special about the word 'nano'.
http://www.ebi.ac.uk/2can/biology/molecules_proteins3.html
Aptamers are definitely not ligands. This is a trivial argument. The term ligand can take many different meanings whereas aptamers are very specific in their description and definition.
This doesn't change the fact that all medicine is done on the nano-level. Proteins can be measured in nanometers. Chew on that!
I've never once been thanked for warning people that they were investing in a scam. It's a shame. I think people who invest in stocks like this ultimately want something else out of life and they're expressing it in the market. Enough psychology...
Nanoviricides can't revolutionize medicine.
HIV is functionally cured. Once-a-day Atripla results in a symptom-less phenotype.
IV Flu drugs is not a big market. It's probably not worth the development cost to make a drug like this. That's assuming these drugs do anything, which is a big assumption.
Dengue direct antivirals will come before NNVC develops anything. A Dengue vaccine will probably obliterate dengue. Nothing there either.
For $200m I see a lot better purchases out there. I would take a shot on the long side if this company was worth $20m, maybe, under a CDA with tons of information, maybe.
Two grams of GLP toxicity grade material should cost $500,000. Something NNVC can do easily. Let's see if they do...
What I meant by that is that it is likely the shares will be cancelled in bankruptcy. So short sellers like me will never have to cover their short shares.
Has there ever been a poster presented at an academic meeting by Nanoviricides?
Any references for the half-life of a few weeks? I am suspicious of this. Most companies report this data in a peer-reviewed way. Since there has never been human exposure we wouldn't know that species but any PK data in any species would be very helpful to legitimize the company.
It's determined easily with radioactive tools. Every drug has a half life. Non-negotiable.
Does anyone know what the half-life of a nanoviricide looks like? This is extremely important in good drug development and I'm not sure it has ever been disclosed.
If an IND filing comes before 2012 I will cover.
Never covering my short on this scam.
I find this somewhat humorous considering all medicines work on a nanometer scale. There is no such thing as "nanomedicine" - all medicine is nanomedicine.
Also I'm disappointed by the fact that he might not even have a pre-IND meeting by 6/30/2011. Given that toxicology and cGMP certification usually takes 12 months at best, it sounds like no IND until 6/30/2012, probably not even by Year-End 2012 given how these guys are generally late.
So Phase I/IND in 2013. Dengue will probably be a memory by then. Or Medivir or Siga will have a drug. Or a vaccine will be closer. All in all, not worth the $200m market cap today. Not by a long shot.
I am one of the large short sellers in NNVC and I report to you I have zero problem as it is a small position in my portfolio and I there are no FTDs. The interest rate on the borrow is small. The average daily volume is 500,000 so it's only 4 days of volume for the entire short position. Shorts are mostly hoping the stock goes up but are not expecting such. Hope this helps!
How does one go about knowing all of this with respect to NNVC?
How does one get to have a really good understanding of the inner workings of one company and ONLY one company?
Wouldn't it get in the way of knowing a lot about the dozens of companies one normally has in a portfolio?
Pre-IND meetings are pre-toxicology. They are to guide what toxicology is neccessary. Toxicology studies are cheap, so the industry doesn't typically look at getting guidance from the FDA as useful, unless the company is very small and on a tight budget. The most expensive toxicology studies are less than $500,000.
>>The goal stated was filing for the pre-IND meeting by then, meaning animal test for all lead candidates would be complete and data vetting finished in preparation for the pre-IND review. It was people posting here who planted the seed that the meeting would be by June, in some cases it was even stated as may in a question form.
I question NNVC's "experience". I think they could have done an IND by now if they were that experienced. Seymour has never worked at a drug company - talk about experience. Diwan also has never worked at a drug company other than IT at Bristol(laughable). SABs and consultants don't run studies - the executives are responsible for writing those checks. So think twice before you assume much about NNVC's executives' experience.
I own 70% and 25% of two public drug companies. Small difference.
Sure I am. I own drug companies. I don't need to clarify or justify anything. I am not a physician and I am a professional investor but it doesn't mean I'm not in the drug business.
Either way, NO ONE uses pre-INDs. It's laughable. The industry standard is you file your IND without asking the FDA. There is very little to ask. Do you really think they care how many mice and dogs you use? You have to have zero experience to not know how to run a toxicology program.
FYI, I am developing a drug and I not going for a pre-IND meeting. There is no point. If you have manufacturing you do quick tox and you're ready. It is REALLY easy. Something is wrong here. The company hasn't explained what they need to do. EG what are they working on right now, what are they waiting for, what is the next step, etc.
Sold to you. I cover at 0.10.
Any private company with this level of advancement trades at $10m pre-money. Good luck to all.
Yep. It's sad to see Seymour and Diwan seem to be the only folks making money out of NNVC.
I believe this is accurate since the owner has disposed of the shares. Gray area of reporting, but it is not policed much.
You hit it on the head. Awesome day.
2 years away from IND. So 5 years if it goes perfectly. No way that is worth the current market cap with simple discounting and probability adjustments.
Without evidence of toxicology/cGMP manufacturing progress I get the sense they may be having bigger problems than planning a clinical trial program.
Anyone excited for annual shareholders meeting 2011?
Vaccine trials take a long time, a few seasons usually, but it will be done and Sanofi is pretty good at this. If they are not successful, it would be good for SIGA, AVII and the other dengue antiviral developers.
That only works if there is a "high" coming.
I doubt this price is the bottom.
The shortest approval of all time was 4 years. The 10-Q says they need 18 more months just to file an IND...