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that was already fully anticipated given previous FDA approval, so should not have been expected to move the stock in any significant way.
Thanks crash. HIV ahead of Dengue? I don't think that is the case but it looks like that's the way it is depicted. I'm thinking that's just because they still need to optimize Dengue so they don't have the final candidate yet, but it will still be run first, ahead of HIV.
Amen.
NanoViricides will lease the cGMP facility to Inno-Haven.
NanoViricides will invest $20m for the construction of the facility.
requrires a LOT of paperwork and approval by the WHO. Originally we were hoping for something by the end of the year but would not be surprised to see that pushed out well into next year. We've not had any input from the company on timing so who knows, maybe they will surprise us.
why has big pharma not already stepped in and provided funding?
Also I still have doubts about efficacy in humans until the first tests are successful.
Nature has a way of adapting and it is an unknown how we and the virus targets will respond.
probably '15 assuming all goes well. The truly inspiring aspect of that is that if the stock gets to that level, it would signify success in humans and with that it would certainly go much, much higher than $70 (equates to a market cap of only $3.5B). So we would ultimately need a planning committee for the numerous follow-on bashes. I'm thinking Weedie will help us out with that...
One side note.... the increasing spread of MERS with it's very high rate of lethality will get more and more gov't attention in the months ahead. With solid test results out of PHE on MERSCide the company could get quite a boost, along with gov't assistance, as we may very likely be the only solution on the horizon.
there is already way too much censorship on this board. Way more than any other board I have ever been associated with.
Yes, but only after a successful Phase I/IIa. Note that they didn't put up the gargantuan $11B bid for VRUS until after completion of Phase II on their Hep C drugs. That timing is pretty typical.
the next stage of tox will be done with GLP materials, no GMP until the Shelton facility is completed and producing. First use of GMP materials will be in clinical trials.
that information is way out of date, is NOT in the latest 10K, and does NOT include mention of the very broad patent issued (PCT/US06/01820
(SOLUBILIZATION AND TARGETED DELIVERY OF DRUGS WITH SELF-ASSEMBLING AMPHIPHILIC POLYMERS) in May of last year.
We have previously announced certain important issuances of patents on the TheraCour® technology underlying our nanoviricides® drugs. Most importantly, a fundamental patent on the polymeric micelles composition, structure and uses was issued in the USA with substantially broad claims. This validates the novelty of our approach as well as our leadership position in the nanomedicines based on polymeric micelle technologies. All of the patent applications have been filed internationally. To date more than 20 patent grants have occurred and additional grants continue as the applications progress through review.
Of the patents and technologies licensed, the Company believes that the Company will not be using the intellectual property, compositions of matter, or other aspects described and secured under the US Patent No. US 6,521,736. The Company believes that this patent describes an inferior technology compared to the technology in the later patent filings of Dr. Diwan. This patent, the Company believes, discloses prototype materials that served to establish the proof of principles developed by Dr. Anil Diwan, the Company’s President and co- founder, whether such materials were possible to create and whether such materials would indeed be capable of encapsulation of pharmaceutically relevant compounds. The Company believes that the new and novel compositions disclosed in the new patent applications, No. PCT/US06/01820, and No. PCT/US2007/001607, and additional proprietary intellectual property provide the necessary features that enable the development of nanoviricides. The Company believes that no other published literature materials or existing patents are capable of providing all of the necessary features for this development, to the best of our knowledge. However, the Company has no knowledge of the extensive active internal developments at a number of companies in the targeted therapeutics area.
You guys seem to want nothing to do with anything that may be seen as adverse and attack it.
We've talked about patents here a number of times. I supposed I was suggesting you delve a little deeper before taking a completely worthless article like that at face value.
I would recommend checking your sources a little more thoroughly.
given everything that has transpired over the last 6 months, to bring up only a sale of shares purchased earlier in the year widely misses the big picture. I suggest Mjzgrk do a little back reading here as well as press releases for the year.
Note that that article was referencing HIVCide.
Dr. Seymour mentioned HCV-Cide in the SNN video and crashco brought forth the September 2013 news article indicating they are developing/optimizing the drug.
a number of years out yet and vaccines traditionally fall far short of 100% effectiveness so many who are vaccinated would likely still have need for an effective treatment. Vaccines can also have significant side effects for a small percentage of the patient population.
Those that are vaccinated with it will not need Flucide but those many who are not vaccinated will.
Love the concept of governments stockpiling flucide and think that would definitely happen.
little chance of a buyout offer until after a successful Phase I/IIa. On successful completion there the stock would quickly move part way toward a value that would begin to reflect annual sales of around $2B or so, give or take. Attach a (conservative in this case) price to sales ratio of around 5 and you can see you would ultimately be heading toward a market cap range of around $10B. Any bid that came in would have to be at a significant premium to the existing stock price. By the time Big Pharma swooped in you would likely have a company already worth at least several billion. Wait until completion of Phase III (or on early approval) and they would probably have to get most of the way to that $10B number. More if Dengue was moving along well also. And of course since the platform would then be validated, any deal price would have to factor in to some extent future drug potential as well.
that was a TheraCour filed transaction for $19,500 (39,000 shares pre-split) on a single occasion back in Jan.
seems to me that is a fairly typical spread between bid and ask for this stock.
It should be obvious to everyone that the pace of developments has picked up considerably of late.
yes, it was a rhetorical question with an obvious answer. I think the terminology here is still being confused (which is why I refer to facility vs. lab....existing facility not to be confused with new Shelton facility). I was referring to scale up in the existing facility, which has been talked about for a long time now.
its been widely acknowledged here that there is a market for both vaccines and cures. NNVC is well ahead of this 2018 timeline.
I think I just entered the twilight zone.
How long now has the company been talking about scaling up in the existing facility?
??
my statement was based on that quote which was obviously made prior to my post.
Wow, the quote is right there for you to read and you still manage to misinterpret. The word "oral" was even highlighted in red for you.
Yes, it defies common sense to think they would be scaling up operations at the existing facility if they didn't think they could save time vs. waiting for completion of the new facility.
you can replace "will have" with "expect to have" if that makes you feel better.
I don't see the reference to cGMP that you claimed I had stated.
I stand by my contention that the glp tox will not be completed in '14 and will be done with material from the new facility.
nothing is a "given" that's not what I am saying. Obviously plans can change, delays can happen at any step along the way. That's the nature of this business. You mischaracterized what the company had said, that's what I was correcting.
Given these uncertainties, I don't consider it a given or "obvious" that they will have material from the existing lab for glp Tox.
you have clearly confused yourself. You stated --
The company has made it clear that glp Tox will be done with material from the new facility.
doesn't matter, you were clearly wrong in your assessment that cGMP materials from the new facility will be used for tox, and that therefore GLP tox can't begin until that facility is producing. That little bit of info should change your timeline but I see you are welded to it despite facts clearly refuting the info you used to arrive at that conclusion.
the GLP TOX, meaning the tox for the INDA, will not be completed in '14.
this should clear it up for you --
Because of the significant safety observed during the several animal studies designed to test the effectiveness of FluCide drug candidates in small animals, the scale required for the tox package studies was estimated at kilograms. Originally we had intended to perform kg-scale syntheses only after the new lab and facilities designed for such scale up was available. However, the facility program was significantly behind due to challenges related to resources availability as well as significant challenges posed by the need for designing complex functionality in a limited space while performing renovation of an existing space. We therefore decided to perform the synthesis of FluCide for tox package in our existing small-scale laboratory. We have been optimizing the processes and translating laboratory operations to appropriate chemical process unit operations in the subsequent time frame. This is a very significant undertaking, given the constraints of our current small-scale facility. After we have completed these process optimizations, we will still need to produce at least three to five batches of the injectable FluCide, analyze the product for comparability, and combine these batches to produce a master batch sufficient to perform the tox package studies with. These activities are currently in progress.
you have misinterpreted.
The company has made it clear that glp Tox will be done with material from the new facility.
it's a terminology thing which he has already acknowledged. The first clinical trial likely being a combined Phase I/IIa in which efficacy is established.
I think the next thing we hear could very well be Orphan status approval out of Europe for Dengue.
(cGMP facility completion has been pushed into Q1).
When that is the case it's because the efficacy was so high and in such a high proportion of patients that statistical significance of efficacy was established in the Phase I despite the very low number of patients.
So IF the results are good enough in Phase I, only the Phase I has to be done in flu season. The Phase IIA can be done after the season in such cases. (so there would be no need to wait for the next flu season to complete the PhaseI/IIa.)
and how many multiples higher are we now since your call for 20 cents? I guess you must have a better vantage point than Dr. Boniuk...