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Shouldn't all the animal testing to date with zero adverse effects be a large part of the tox presentation? How much more could possibly be required?
Isn't the pre-INDA coming in the next three months? This is what I have been led to believe. If so, and tox studies and confirmation are presented by caledar year end 2011, why should it take twelve more months to get to Phase 1 human testing?
The Cox effect seems to have disappeared.
Is there a rational explanation for the perverse reaction of NNVC's SP to what is apparently very good news?
The FDA can't do anything until they are approached by NNVC. It's the fear of the unknown that has everyone tied in knots. This discovery is so mind-blowing, life-changing and technologically disruptive that the FDA will ignore or disrespect it at their own peril. They'll have the scientific and political world on their backs.
Maybe Dr. Seymour should be in contact with the Israeli equivalent of the FDA as a backup plan. I'm sure they would love to have these CIDES in their medical arsenal. (TEVA anyone)
It's his playpen. He developed the process and owns the patents. More power to him. No dilution and a cGMP. Sounds good to me.
You have to get to an FDA approved product first. My question is, how long will that take?
Dr. Feelgood, does the time necessary to realize this facility give any indication of when toxicology studies can/will begin?
Ho-Hum. So much for the good news. No one seems to care but us I-Hubers.
Keltoi, what is your confidence level that NNVC will initaite the preINDA with the FDA by September?
it looks like someone just unloaded fifty thousand shares.
Apparently no one at Dr. Seymour's presentation in Denver or Dr. Diwan's presentation in Boston were sufficiently impressed to make a major investment in NNVC.
I don't believe we've had any report or update from Dr. Harris in a year.
That was a year ago.
Amen to that.
Amen to that.
Flucide isn't on the agenda until Thursday.
I looked at the program for the TechConnect Conference. Dr Diwan is speaking Thursday at 11:20. There are hundreds of presentations this week. I hope his does not get lost in the clutter. Past presentations have not evoked a torrent of interest in NNVC.
Lots of maybes there.
Again----nothing!!!!
Typical government gobbledygook. Another do-nothng committee to spend more money. There are plenty of agencies and bureaus to get the job done without creating another one. So much for the reducing regulations campaign.
Hi, Kelt. I believe there have been revelations in the past five years that conversations and presentations have been made to the FDA through conferences, seminars and other federal agencies. I don't see how they could be that unfamiliar with NNVC's science. It's not that it's been kept under wraps.
Did Dr. Seymour reveal any tidbits of information that you might share with the rest of us?
Doc, do you think we're really a year-and-a-half to two years from completion of tox studies and ready to file the IND? Diwan has been working on this for twenty years.
Nothing new in that release.
Wasn't this HIV data the purported basis for the presentation in South africa that was aborted?
Has anyone asked Patrick Cox or John Mauldin what date they believe he was referring to? Nowhere in the conversation is "Fiscal Year" mentioned.
I would say that Dr. Seymour is revising history to suit subsequent events. I don't care, if he'll just get it done by June 3oth. That is what he said and no dissimulation to the contrary will make me think any differently. Enough is enough. Just level with us.
Come on, Doc. If you're conducting an interview in October and refer to something happening after the first of the year you wouldn't be referring to July. I fear you are becoming an apologist for NNVC and its management team. They have misled investors so many times that it is impossible to attach much credence to anything they say.
The post was # 39919 on Oct 13, 2010 and included Patrick Cox and John Mauldin. The comment I referenced was around paragraph 20.
Doc, as I recall, it was in the dual interview with Cox and the other investment adviser, whose name eludes me. He hinted at some news by the first quarter and presenting an INDA to the FDA before the end of FY 2011 (June 30).
Dr. Seymour, intentionally or unintentionally, created this deadline when he granted an interview to Patrick Cox last November. It is now the albatross he must wear. I predict severe hits to the SP if there are not substantial news releases prior to June 30th.
It has been previously reported that due to the unique treatment mechanism and the limited life cycle of the targeted viruses, that the three human testing phases should move forward very rapidly. If one assumes pre-IND approval is achieved by year end 2011, when should we expect final approval after phase 3?
Doc, are you now telling us that the pre IND will not be done before year end and the IND started until late 2012? Pray tell me what the hell is going on at NNVC? The goal posts have not only been moved, they have disappeared over the horizon.
I too have been long NNVC for almost six years. I have been mostly patient as progress has been made. To date, all tests have been positive and all results good. But, after all the excruciating waiting, I believe management must now either "fish or cut bait."
His age doesn't matter. His clinical experiences at NNVC, Harvard, Dana Farber, Lilly, et al, do. Get over it.
The 'operative' word is 'inches.' For once I'd like to see a 'leap'.
Where is Inspector Clouseau when you need him?
News is the reporting of results—of all kinds.
What an insipid and mean-spirited comment. You have no idea how Dr. Seymour spends his day. He has logged hundreds of thousands of air miles in building NNVC into a future block-buster Biotech giant. Just be quiet and watch.