Replies to post #146254 on NanoViricides Inc (NNVC)

[MiQuant]

There is a reason why the indian CEO of NANOVIRASCAM, Anil Diwan, makes the Clinical Trials in INDIA. INDIA is one of the most CORRUPTED countries on earth. This makes it easy to "buy" results in Clinical Trials, and hide adverse cases and/or geno/neuro-toxicity from the nano particles (aka nanoviricides).

India’s CDSCO medicine regulator is criticised for quality checking only cough medicines destined for export
(Published 14 December 2023) News LINK: https://www.bmj.com/content/383/bmj.p2951


Kamala Thiagarajan

India’s system for regulating medicines has been questioned after an investigation found that more than 100 cough syrups made for the export market failed quality tests.

Specialists have said that the Central Drugs Standard Control Organization (CDSCO), the national regulatory body for pharmaceuticals that conducted the investigation, lacks the necessary oversight to ensure that medicines manufactured in India are safe.

The comments follow a report from CDSCO shared with the media on 4 December on the results of tests conducted on more than 2000 cough syrups. Of these, 128 syrups manufactured by 54 companies, which were meant for the export market, were found to have problems with quality.

In June this year India’s director general of foreign trade mandated that cough syrups meant for export must undergo tests at a government laboratory and must be authorised with a certificate of analysis before they can leave the country. However, Dinesh Thakur, a public health activist and coauthor of a book about drug regulation in India, questioned why the policy was limited to just one type of medicine.

“Clearly, the outrage associated with the deaths of the children has resulted in this action, but this only applies to cough syrups,” he told The BMJ. “If this is the case with one class of medicinal product, what about the rest?” He added that it was not clear whether companies found to be in breach of standards would face any consequences.

[KMBJN]

In order to determine if NNVC's NV-387 IND package is good enough for FDA, NNVC needs to actually submit it to them. It remains puzzling why NNVC goes so slowly with FDA and clinical trials, other than that Diwan is a cowardly and greedy control freak (loves the gravy train, afraid to try because that means the drugs might fail and the whole gig would be up), or maybe they are still working out some manufacturing issues, or there is some other unknown reason why it has taken them so long to apply for an IND and take one of their many 'cides into trials in the US after all these years. If I recall correctly, the last communication was that NNVC was going to have a pre-IND meeting, and think about submitting an IND for NV-387 by the end of 2025. They are hoping their NV-387 that targets HSPG binding viral antigens will be an oral, broad spectrum antiviral, good against multiple (respiratory) viruses like RSV, CoV, and IAV (fluA). It's WAY WAY overdue for them to plan and get into a human trial. They move SO SLOWLY that it is bewildering. That said, they did seem to show that NV-387 was safe in humans with their Phase I India trial, with NO dose limiting toxicity, and this data will surely be part of their IND submission to FDA, along with their planned Phase II trial against multiple respiratory viruses. People can and will continue to shout fraud here, without presenting any solid evidence of said fraud. Hard to know what to believe. The truth will come out some day. That day keeps getting closer and closer as NNVC finally does a trial to see if these nanomedicines work, or they run out of money, or something. It will be interesting to see if they can get a partner to fund and run the trial.