On 2015 Mar 19, Donna Beales commented:

My understanding is that there was a change to the formulation of the suspension medium used in some trials with T. suis ova. Such alterations could conceivably have unanticipated effects on living organism therapies. Quoted as follows: All prior and very successful studies, this final formulation was of a pH value between 2.7 – 3 and had no preservative, while for the TRUST and some other newly pilot studies on other indications a formulation of a pH value of 5 plus potassium sorbate as a preservative was used... Nevertheless, the decision of changing the formulation for the drug approval studies is understandable if one takes into account what the common practice is in normal drug development according to the pharmacopeia, but a living organism does not necessarily fit into these regulations designed for single molecules and chemical compounds."

Too, 12 weeks may not be sufficient time for clinical efficacy with a living organism; even pharmaceutical immunosuppressants may require a period of several months for full effectiveness. "Another critical issue in the TRUST studies was that the endpoint was set after just 12 weeks of treatment, which is known to be the time frame where the agent just begins to unfold its mode of action effectively." Source: http://tanawisa.com/news/

These factors are relatively unknown, and should be considered in any interpretation of study conclusion.

On 2015 Mar 19, Donna Beales commented:

My understanding is that there was a change to the formulation of the suspension medium used in some trials with T. suis ova. Such alterations could conceivably have unanticipated effects on living organism therapies. Quoted as follows: All prior and very successful studies, this final formulation was of a pH value between 2.7 – 3 and had no preservative, while for the TRUST and some other newly pilot studies on other indications a formulation of a pH value of 5 plus potassium sorbate as a preservative was used... Nevertheless, the decision of changing the formulation for the drug approval studies is understandable if one takes into account what the common practice is in normal drug development according to the pharmacopeia, but a living organism does not necessarily fit into these regulations designed for single molecules and chemical compounds."

Too, 12 weeks may not be sufficient time for clinical efficacy with a living organism; even pharmaceutical immunosuppressants may require a period of several months for full effectiveness. "Another critical issue in the TRUST studies was that the endpoint was set after just 12 weeks of treatment, which is known to be the time frame where the agent just begins to unfold its mode of action effectively." Source: http://tanawisa.com/news/

These factors are relatively unknown, and should be considered in any interpretation of study conclusion.