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Perfect!
How much would a successful antiviral platform be worth? Approval of FluCide would validate the entire platform and send the stock soaring into the stratosphere before they sell a single dollar's worth of product. Here's an example of what can happen pre-revenue to a stock with a single drug that addresses a potential multi-billion dollar market. PCYC's market cap today stands at over $9B and they have yet to receive FDA approval. NNVC will be targeting markets far in excess of that of the drug mentioned here --
For Pharmacyclics, it is an old company that produced absolutely nothing for 15 years. Then, all of a sudden, Pharmacyclics either stumbled across greatness with ibrutinib or underwent a change in culture to develop ibrutinib. Either way, Pharmacyclics was a $60 million company in 2009, and with no expectations. Then, the upside and potential of ibrutinib reversed the stock's trend, and quickly.
To make a long story short, ibrutinib became noticed, and peak sales potential slowly rose from $500 million, to $1 billion, to $3 billion, $6 billion, and now some are even saying $9 billion. During Pharmacyclics' four-year 10,000% return, the company has not sold one product, but the constant re-assessment of potential for ibrutinib pushed shares higher, that and a few breakthrough designations.
The Fall 2014 date to start clinical Phase I/IIa in Australia works with the season, although the timing is late in the season - meaning enrollment at a single clinical site may be slower for the efficacy portion for flu-infected patients. But there are only 24 patients total planned (not sure how many healthy patients for safety or sick patients for efficacy), so maybe no significant impact on timing.
NNVC has demonstrated a product that works in animal tests. Vecoy has done only a demonstration in a petri dish.
Ok, I think that is the plan... a combined Phase I/IIa has been estimated by the company at 4 to 6 weeks. I presume it will take some additional time to get it written up.
(I think it was 25 or 40 subjects, depending on availability of rooms).
Phase II's are *usually* the earliest that efficacy can be demonstrated. But IF a drug has both very low toxicity AND very high efficacy, statistical standards for efficacy could be made in Phaase I if the number of patients is sufficient.
redistribution.... it plays well with the masses.
so your own hypothetical gets easily shot down and right on cue you redirect with another red herring. Too funny.
I think it is virtually assured you are posting at recess again.
That's not a big advantage when you consider that both are followed by 6 years or so of further development and testing before they are approved. It comes down to 6 years total vs. 8 years.
I see you caught yourself. Next time at least verify what you are saying before you post.
don't quote me out of context, it makes you look really juvenile. What I said was that if early trials go well, a Breakthrough Therapy designation is "virtually assured" for the treatment of severely ill hospitalized and immuno-compromised patients. It would meet all the requirements.
though your timeline is exaggerated in this case, of course it is true that any new candidate developed by any company would have to be validated and tested. So the relevant question becomes, how does a week or 2 stack up to drug discovery timeframes for the rest of the industry? What do you suppose big pharma typically spends, in time and money, to discover a single candidate that is promising enough to be advanced into preclinical testing?
Fair, honest question: why are the patents only licensed to NNVC and not owned by NNVC? Could Theracour just pull the license on NNVC?
right, and they duped the FDA into granting them Orphan status and they fooled Public Health England into testing their fraudulent concoctions. This really gets ridiculous.
The TheraCour transaction was not a sale, it was payment to a contractor who elected to take stock as fee for services in the amount of $19,500. You should really look at things with a more discerning eye.
Diwan sold stock to help finance the new facility. And the amount of stock sold wasn't even close to his total personal investment in same. If you think it may be a scam in spite of all obvious evidence to the contrary then you may believe in unicorns as well.
of course that is on top of the $6M put in by the group of Drs. in Feb and the millions Diwan has put into the new facility. If you are still taken in by the scam suggestions I don't see how you would ever have the analytical abilities to make an intelligent investing decision.
there have been good arguments over the years for both sides of the fence, that it is a revolutionary new technology or a total scam. I don't know.
with success in early trials, you can absolutely count on accelerated status. There is no valid reason it wouldn't be granted with hospitalized flu patients dying every year. So yes, I stand by "virtually assured."
yes, of course, that is assuming positive early trial results.
I don't think you have gone over the criteria very carefully. They are virtually assured of the new "Breakthrough Therapy" designation for treatment of severely ill hospitalized and immuno-compromised patients.
no competition here as Malaria is not a virus and therefore not a potential target for NNVC --
Malaria is a parasitic infection spread by Anopheles mosquitoes. The Plasmodium parasite that causes malaria is neither a virus nor a bacterium - it is a single-celled parasite that multiplies in red blood cells of humans as well as in the mosquito intestine.
Absolutely, biotech in general has been getting killed the last few days. NNVC is holding up pretty well by comparison.
Hey, anything for the cause.... I will endure! (But it might not be pretty).
I believe this was an update to that (from recent 10K)--
The Company has signed a Memorandum of Understanding (MOU) with Inno-Haven, LLC, for the total renovation of the 1 Controls Drive, Shelton, CT, facility purchased by Inno-Haven into a pilot scale cGMP facility and associated R&D laboratory space. Inno-Haven is controlled by Anil R. Diwan, PhD, our founder. Inno-Haven has raised substantial amount of capital for this project through various sources, and it is expected that they will be able to raise all of the necessary funding for this project, with minimal capital expenses to be borne by NanoViricides, Inc. The Company is expected to lease the facility. The terms of the lease are expected to be negotiated after the total cost of the facility can be determined to a substantial extent. No lease has been signed yet. The project is already in construction phase, and is anticipated to be completed in the first calendar quarter of 2014, if no additional delays such as long lead times or back orders on equipment etc. are encountered.
Not yet, I don't want to peak too soon!
changes -
I think the Shelton facility is now scheduled for completion in Q1.
All ladies on the attire committee I presume?
My grass skirt is in pretty good shape but my coconuts will need some enhancement.
THe only thing that would make flucide eligible is saying it is potentially superior to the annual flu
shots.
Flucide is unlikely to be granted this as it is not likely to be a pandemic or other extreme circumstance to warrant to status.
What you refuse to acknowledge, and continue to dance around, is that the "real" toxicity trials will not be expedited by this delay.
I think they are almost certain to qualify for the new "Breakthrough Therapy" designation.
What are the differences between the breakthrough therapy designation and the fast track designation?
Although breakthrough therapy and fast track designation programs have similarities, as they both are intended to expedite the development and review of drugs for serious or life-threatening conditions, there are differences in what needs to be demonstrated to qualify for the programs. A breakthrough therapy program is for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies. In contrast, a fast track program is for a drug that treats a serious or life-threatening condition, and nonclinical or clinical data demonstrate the potential to address unmet medical need.
Phase I/IIa combined have already been estimated at only 4 to 6 weeks total, so I don't think you are going to save any time there. The time saved by doing non-GLP tox is achieved in GLP (regulatory) tox studies as detailed in this description of non-GLP studies posted below by incubus --
Thus, a rapid assessment of the toxicological profile of the NCE can be made to establish initial safety facilitating conduct of subsequent regulatory Toxicological studies and potentially earlier entry into clinical trials.
The tox tests announced today will not bring the cides to market any faster.
thus would require a few additional weeks of animal testing before starting tox testing in humans
the plan for some time now has been to conduct initial trials in Australia.
In the past the company has said that beginning tox depended on both their and BASi's schedule. So it's possible that waiting on BASi might have delayed start by a few months and they were able to start right away at KARD with the non-GLP portion of the study.
Yes, though we are still faced with completing scale-up and production at the current facility to produce the materials necessary to complete the GLP study at BASi. I think it is prudent to consider that that could still potentially be a source of delay.
Tox should normally take about 6 months and then an additional few months to write up. Timing wise, that would dovetail fairly well with completion of the cGMP facility (Q1) and production of the cGMP test batches (Q2?) in preparation for human trials. So things could start to come together nicely around Q3, depending on how quickly they can scale up the existing facility to produce materials for GLP tox studies. I think it is a tough call on whether they can start human trials in Q4, but even if that were to slip a couple quarters, it doesn't change the investment thesis at all in my opinion.
Hopefully that gives you time to train. (large backpack, steep hills)
ahhh, take your flogging by yourself then!
Erez Livneh, M.Sc, is the Founder and CEO of Vecoy Nanomedicines. Prior to founding Vecoy, Erez spent a decade conducting and leading bioresearch programs in both academia and biotech companies, including Compugen (NASDAQ:CGEN)