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Did you notice the dates…2006 and 2007. And these plans never materialized.
I'm shaking my Pon Poms over here! Go NNVC! Can't wait to meet everyone at the big celebration party in Hawaii!
KMBJN as you are a confidant and steadfast supporter, I'm curious what you think the next steps will be in this company's progress and when you believe we should expect to see them?
Thanks for your POV, always interesting.
If a company says it "has developed " something that is not the same as them saying "they are developing" something.
“Developing a drug” and having “developed a drug” are not the same thing with one just being more precise. Nor is it a distinction without difference.
They are completely different factual conditions.
The good news is my magic carpet is 100% developed!
Like arguing about the use of the word "drugs"?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=163547419
“If the facts are against you, argue the law. If the law is against you, argue the facts. If the law and the facts are against you, pound the table and yell like hell”
- Carl Sandburg
I don't believe logic and common sense were used.
Really? You don't believe logic and common sense should be part of a company's decision making when it comes to NOT continually changing focus and priorities so as to NEVER bring a drug to the FDA?
I wasn’t referring to anyone, I was referring to the company.
The cream that they claimed to have made 220 lbs of was a fully realized nanomicelle formation. It was for VZV.
Why would a company continually abandon existing progress and restart for a new “flavor of the month” as you call it?
At some point, I have to believe logic and common sense will play a roll.
But maybe not
Maybe you missed this. Hope it helps:
the cGMP-like manufacture of both the active pharmaceutical ingredient (API, the nanoviricide against VZV), and the fully formulated skin cream (the drug product candidate), was accomplished at our own facilities at ~1kg scale (API), saving us millions of dollars and at least one year’s worth of time, as opposed to going to an external contract manufacturer. Approximately 10kg of fully formulated drug product has already been manufactured. We believe this scale is sufficient for the requirements of Phase I human clinical trials.[/I]
Fully formulated
Now where did I read that they had not achieved single batch scale up to levels required for testing but instead were combining multiple batches (which isn't admissible for FDA)?
(Hint: author’s initials at NT)
You haven't heard anything about reproducibility of product?
From most recent filing:
Of note, the cGMP-like manufacture of both the active pharmaceutical ingredient (API, the nanoviricide against VZV), and the fully formulated skin cream (the drug product candidate), was accomplished at our own facilities at ~1kg scale (API), saving us millions of dollars and at least one year’s worth of time, as opposed to going to an external contract manufacturer. Approximately 10kg of fully formulated drug product has already been manufactured. We believe this scale is sufficient for the requirements of Phase I human clinical trials.
Our current multi-kg per batch scale of cGMP manufacturing capacity is expected to be more than sufficient for the anticipated Phase I and Phase II human clinical trials. In addition, we believe that our facility can supply required quantities of the drug for Phase III clinical trials as well. Thus, this in-house cGMP production capability is expected to result in significant cost savings across all our programs.
The rapid success of translating the research scale production of several grams drug substance in early CY-2018 to kg-scale cGMP manufacture in early CY-2019 was a result of the tremendous subject matter expertise of the team. External contract manufacturing organizations would likely have required at least three years to scale up these complex products, based on certain discussions we have had.
We have developed strong chemical manufacturing process controls that enable us to produce the backbone polymers with highly restricted and reproducible molecular size range. In fact, we have achieved highly reproducible and scalable processes that have yielded the same polymer molecular sizes across production scales from 10g to 500g. In other words, we are now able to control the length of the backbone polymer to within one monomer unit, irrespective of production scale, at least up to about 1 kg scale.
We believe that this is a remarkable and possibly unmatched achievement in the field of nanomedicines. We have scaled up the production of the polymer backbone “nanomicelle” to multiple-kilogram scales, and do not anticipate any manufacturing constraints at present. We have also achieved kilogram-scale manufacture of the ligand in NV-HHV-101, and have further scaled up production of the nanoviricide NV-HHV-101, which is chemical conjugate of the ligand to the nanoviricide, in a well defined manner to kilogram scale. Additionally we have scaled up formulation of the resulting drug substance into the skin cream to multi-kilogram scales. The production of the drug substance and the drug product is achieved in a cGMP compatible fashion at our own facility.
#2: Bingo!
But THIS time is different.
HA!
The problem is that we are using the terms “drugs” and “compounds” incorrectly. We should focus on semantics and not the complete lack of legitimate and VERIFIABLE progress for the past 15+ years.
And let’s be sure to attack the messengers regardless of the accuracy of their claims.
But THIS time is different!
No, THIS time is different!
Hoho,hehe,hahaha
I am astonished that people Keep Making Bogus Justifications for Nanoviricides.
Yeah, flying on my magic carpet is rewarding too!
I'll save you a seat next to the unicorn.
I’m calling BS on this. 99% of the Reddit “investors” have no idea what a naked short squeeze is. They invest based on propaganda and passion.
I believe this post contradicts itself. But I truly appreciate your insight and finely detailed and well supported observations.
Thank you for this very helpful post.
Your post describes how scams work and your knowledge of and willingness to explain is very valuable.
It’s clear from your post that the company is not responsible for the poor performance and lack of progress.
Thank you so very much.
Yes, I couldn’t agree with you more.
I really appreciate you’re perspective on the company. Always great to hear from someone with such a similar perspective.
Thanks buddy!
Really? Now where did I hear that there wouldn't be any tox completed in '20, '19, '18, '17, '16, '15...?
https://www.sec.gov/litigation/admin/2016/34-79396.pdf
The Commission’s order related to violations of the auditor independence rules by Rosenberg Rich Baker Berman & Company (“RRBB”), a registered public accounting firm, and Zucker, a partner at the firm. Zucker performed Financial and Operations Principal (“FINOP”) services for a broker-dealer client, (the “Broker-Dealer”), while RRBB was serving as the Broker-Dealer’s auditor. Zucker also arranged for RRBB to pay a contractor who was serving as the Broker-Dealer’s FINOP and directed an RRBB staff accountant to provide FINOP services to the Broker-Dealer. As a consequence of this conduct, Zucker and RRBB engaged in improper professional conduct, violated the auditor independence rules, and caused the Broker-Dealer’s failure to file an annual report audited by an independent accountant.
He will fit right in at NNVC!
I’m not sure they ever had a pre-ind meeting. That release was announcing Th e FDA’s feedback on the INDA.
So NNVC had submitted an application, and the FDA gave feed back.
I’m just not clear whether or not NNVC had a pre-INDA meeting before submitting the application..which as you and the FDA have said is STRONGLY recommended. Looking at the release, it says the FDA gave written feedback, so it would appear that it was not a meeting.
Has NNVC had a pre-INDA meeting with the FDA for any ‘cide (herpes, shingles, covid...)?
Re-read their guidance.
They are emphasizing the need to have a thorough pre-Ind meeting. These meetings are not mandatory, though strongly recommended.
They are not saying any processes have been accelerated. They are simply restating that a thorough pre Ind meeting can potentially make the rest of the process run faster and smoother.
Yes, they are consolidating the pre ind meeting REQUEST and the package development process into a single step, but that isn’t an accelerated approval process.
But this time is different.
Flavor of the month: covidcide
Bwahahahahahahahaha!
Here's all you need to know about why one discovery is credible and one is not:
Producing single batches in multi kg scale has not been achieved.
(IMHO and based on nothing but things I make up)
I never called anyone stupid.
I do however agree that the definition of insanity is doing the same thing over and over again and expecting different results.
Remember, no clinical trials can begin until the INDA is submitted. No INDA has been submitted by NNVC for ANY 'cide yet.
This statement from the company is misleading:
Last week I read somewhere that this might happen.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=157954235
From their website:
Small Caps Daily is a paid advertiser and is not offering securities for sale.
This is NOT a news article by a journalist. It is paid placement.
Why would a company with such supposedly great results and developments need to PAY someone to shill for them?
While it may appear that my magic carpet and water powered car are scams, I have yet to see any concrete evidence of fraud.