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Does the beginning of human trials in Australia depend on a) completion of tox testing in the US or b) availability of flucide product from the new Shelton Lab?
It was in an interview at least two years ago. I don't know if Dr. Seymour stated that Dr. Diwan would build out the lab and lease the whole thing back to NNVC or not. The plans now are for all operations to move to Shelton. Who will own the building and improvements?
The implication by Dr. Seymour three years ago was that the cGMP plant could be built off-site and then dropped into the Shelton facility in a short period of time at minimum expense. That no longer appears to be the case. I hope a firm cost estimate and time schedule is forthcoming at the Jan 17 shareholder's meeting.
I hope this announcement will inspire a stronger sense of urgency for NNVC's management team.
Yes. Australia is independent of USFDA.
My interpretation is completely different from yours. I believe testing will be done with the oral FLUCIDE, and that is what the West Haven lab is currently producing in sufficient quantities to proceed with toxicology testing. If NNVC is not ready to do TOX testing in 2013 then why did they engage the Indiana company to prepare for testing? Why don't you go to the annual meeting and speak to the horses's mouth.
I received the following from Dr. Seymour today.
"I can tell you the following since it's already public information.
For the FDA to accept GMP designation, it's all about the paperwork. Many countries are satisfied with operations under GMP conditions which is what we'll have. We'll finish the paperwork and get the inspection while we're in human trials offshore.
Australia has nothing to do with the USFDA.
Toxicology can be done with research materials, not GMP materials so they can start as soon as the material is ready for testing.
Sincerely, Eugene Seymour, MD, MPH
I sent a list of questions to Dr. Seymour asking for clarification on toxicity testing and human testing. He responded that they were good questions and would be responded to at the annual meeting since that is an open forum.
If you'd like to get a little feel for what NNVC is going through just watch "Living Proof" starring Harry Connick Jr.It's the story of one doctor's crusade to get the cancer drug 'Herceptin' approved by Genentech.
Looks good to me.
$100 by 2015. Still possible. I'm holding.
On what data or basis do you make that statement?
It appears someone is trying to buy 80,000 shares, slowly accumulating.
Thanks. My response was not a criticism. It was a general recognition that the FDA is a bureaucratic, sclerotic, arm of a dysfunctional government, and can be faithfully relied upon to screw things up.
The issues surrounding injectable antibiotics should have no bearing on the approval of orally administered FLUCIDE, since there is no intra-cellular mechanism. But, knowing the FDA there will be roadblocks.
I'm still here. See you in Hawaii. I'm practicing with a Hula Hoop.
Leif, I'm afraid there is a rationale for what they are doing. It's the same as it's always been. Drive down the stock price for the shorters and the swing traders. As long as it works they'll keep doing it. We just don't have to legitimize their tactics.
Thank you for your concern, but there is nothing we can tell Diwan and Seymour about GLP and cGMP testing that they don't already know.
So you pretty well want to be able to say "GOTCHA." I trust there is something more redeeming than that in your life.
And what are you going to do when it hits 41 pennies?
Someone bought a large block of stock around 3:45.
Dead board or dead bored?
We longtime NNVC'ers have been experiencing these aggravations for a long time. It seems that the Docs have great difficulty meeting their own projections, to the point now that they don't even make any for fear of having their failures pointed out to them. It appears to me that they now have everything they need to move forward with expediency. I don't understand why they insist on waiting for a Shelton cGMP lab. They have sufficient Intellectual Product protections to allow them to partner with an existing manufacturer without fear of someone copying their viricide. Just do it!!!!!!
I interpret Dr. Seymours answers to Leifsmith as saying that all materials through TOX testing and Phase 1 Australian trials will be conducted with NNVC lab produced GLP materials, which meet cGMP-like standards. From that point forward all tests must be conducted with cGMP approved material, either from the new Shelton facility or from an outside FDA approved cGMP facility under contract/license.
If NNVC plans to license or partner its products why does it need a cGMP lab at all? One would assume the partner will have such a lab or can contract for one. I say forget the lab and its expenses and go find a licensee/partner. After they have a billion dollars in the bank, they can build all the labs or not.
If it is still true that we can get through TOX testing with current GLP lab manufacturing and if NNVC will swallow its "go it alone" pride and contract for cGMP manufacturing,there is no reason that Phase 1 human trials in Australia cannot begin by May, 2013. I have always assumed (and the docs have said) that a partnership would be required for production materials. Why not identify a partner sooner rather than later that can fulfill both objectives--CGMP and production.
Things have gone smoothly (but agonizingly slowly) for 20 years since Diwan made his breakthrough discovery. There have been no reported failures in any tests during that time. On what basis do you predict they will stop going smoothly?
So much for the good news about tox testing.
It was concrete news that the testing has been contracted for and the protocol passed on by FDA. There is now a name associated with the toxicity tests with a reputation to protect. Also a tacit commitment by NNVC to producing sufficient drugs for the tests. (But still no concrete timelines)
I agree with you that a thinly traded stock like NNVC is not appropriate for trading algorithms, it is event driven. I was just hoping that this morning's event would drive the stock value up. Maybe when it has time to soak in it will.
Based on this afternoon's action, MATTSTATS might not have to wait until January. Down on large volume. Not a good indicator coming off a positive PR. Just broke below .50.
What does that mean? Will BASI both produce and administer the drugs or will NNVC provide the drugs for BASI administration. Where will the very large quantities required come from? What has NNVC been doing about the New Haven cGMP for the past eight months? This PR created more questions for me than it answered,
Leifsmith and Crashco, I appreciate and agree with both your positions. After seven long years of waiting I hope you are right. I have to remind myself occasionally that Diwan and Seymour have much more at stake here than I do. However, a little more positive information liberally sprinkled along the way would make me feel better about the eventual outcome.
What degree of confidence do you have that human trials will start in Australia in calendar year 2013?
NNVC hired consultants to help them get through the FDA. They hired an affiliate of those cosnultants to perform human oral flucide trials in Australia. They hired a retired Pharmaceutical company employee to build a cGMP lab. They hired a CPA to help with their financial reporting. Does anyone on this board (or elsewhere) have any idea what any of those four hires are doing?
However, this is typically when the bashers fill the vacuum.
Is the IHub site down or has absolute apathy settled in?
This patent application sounds peculiarly close to the Diwan patents.
You forgot Euclidean geometry.
That was for 50%,we still get the revenue stream from the other 50%.