In
a filing with the Securities and Exchange Commission dated
November 2018, months after Moderna had claimed to have fixed the issues with its lipid nanoparticle delivery system, the company made several claims that appear to contradict its purported development of a new, safer nanoparticle technology.
For example,
the filing states on page 33:
Most of our investigational medicines are formulated and administered in an LNP [lipid nanoparticle] which may lead to systemic side effects related to the components of the LNP which may not have ever been tested in humans. While we have continued to optimize our LNPs, there can be no assurance that our LNPs will not have undesired effects. Our LNPs could contribute, in whole or in part, to one or more of the following: immune reactions, infusion reactions, complement reactions, opsonation [sic] reactions, antibody reactions including IgA, IgM, IgE or IgG or some combination thereof, or reactions to the PEG from some lipids or PEG otherwise associated with the LNP.
Certain aspects of our investigational medicines may induce immune reactions from either the mRNA or the lipid as well as adverse reactions within liver pathways or degradation of the mRNA or the LNP, any of which could lead to significant adverse events in one or more of our clinical trials. Many of these types of side effects have been seen for legacy LNPs. There may be resulting uncertainty as to the underlying cause of any such adverse event, which would make it difficult to accurately predict side effects in future clinical trials and would result in significant delays in our programs. (emphasis added)
The November 2018 SEC filing makes other statements regarding its supposedly fixed lipid nanoparticle delivery system that are worth noting:
If significant adverse events or other side effects are observed in any of our current or future clinical trials, we may have difficulty recruiting trial participants to any of our clinical trials, trial participants may withdraw from trials, or we may be required to abandon the trials or our development efforts of one or more development candidates or investigational medicines altogether. . . .
Even if the side effects do not preclude the drug from obtaining or maintaining marketing approval, unfavourable benefit risk ratio may inhibit market acceptance of the approved product due to its tolerability versus other therapies. Any of these developments could materially harm our business, financial condition, and prospects.