Replies to post #677521 on NorthWest Biotherapeutics Inc (NWBO)

[DocLee]

Ex, Apceden looks to be an almost exact copy of the DCVax family in its method of production by a company in India which does not recognise Patent Law when it serves its own purposes, made in a very similar (if not exactly the same) method (ie it is a pirated product) and was approved by the Indian regulator, the Central Drugs Standard Control Organisation (CDSCO). Chat GPT comments thuswise on the Indian Regulator:

The Central Drugs Standard Control Organization (CDSCO) in India, which is responsible for regulating pharmaceuticals and medical devices, has faced allegations of corruption and regulatory lapses in the past. There have been instances where the CDSCO has been criticized for not effectively regulating the pharmaceutical industry, leading to concerns about the safety and efficacy of drugs and medical devices in the Indian market.

Apceden is not licenced for use in any countries regulated by the MHRA or FDA or the European Medicines Agency and one wonders about the ethos in which the CDSCO works. I would suggest that considering that Apceden appears at worst to be a pirated version of DCVax or at the very least a very close copy that avoids patent infringements and was approved in 2017 by the CDSCO (and no other regulator) that it is a somewhat "tarnished" product. Consequently, whilst your claim that it was the second dendrocytic "therapeutic vaccine" after Provenge (licenced in 2010) might be correct, it is possible that other pirated versions of DCVax are produced elsewhere in other countries without adequate regulatory control. Consequently, it is my belief that we should be dealing only with ethical treatments licenced in jurisdictions of the highest probity such as exists with the MHRA, the EMA and the FDA. On this criterion Apceden fails. However, I must congratulate you (or, more likely, your sponsor) for digging up these obscure products from the murky parallel world of pirated copies licenced by dubious regulators.

I have no knowledge about AF making the same claim about BCG as I did, but if he was claiming that it was not a "therapeutic vaccine" I would have agreed with him despite him being an odious character.

As for Imlyglic, even the company does not claim it has an immunologic effect:

Inserted GM-CSF may recruit and activate antigen-presenting cells, which can process and present TDA to promote an effector T-cell response. The exact mechanism of action is unknown and is not meant to imply clinical efficacy.[my emphasis]