In an article titled “Polysorbates, Immunogenicity, and the Totality of the Evidence” author Edward T. Maggio, quotes Dr. Dolinar’s testimony at the FDA pubic hearing, saying:

“Unwanted immunogenicity is the preeminent safety challenge associated with all biological therapeutics and can result in unexpected and sometimes severe adverse effects. Complicating matters, side-effects may only appear in patients after higher doses or prolonged duration of treatments and may be attributed to a number of patient, disease, or product related factors.”

Read the full article here.