I admit that I fall into the category of one who believes the trials are unjustifiably small for Phase 3 trials with large patient populations and theoretically easy recruitment. This combined with the lack of an SPA makes the trials feel like Phase 2 trials.
Because the anemia trials are so small and one trial is in Europe, I want to know what the company is doing to mitigate the risk of trial center error, patient dropout and non-conformance, etc.
For this few patients I urge the company to immediately add one fulltime employee (experienced RN or even a physician) who is travelling extensively and therefore able to "touch" every patient and personally monitor the record keeping and protocol compliance of every trial center.
Since there is no SPA, I ALSO urge the company to add 25-35 patients to each trial.
Thank you.
Disclosure - Still long 24,700 shares but very nervous because of what I perceive to be unwise scrimping by management.