Titan Pharmaceuticals Inc (TTNP)

[Doctor Detroit]

This is ridiculous. Quote from Fox News article:

Cidambi also questioned the removal process. She cited a simulation study in which doctors were required to remove all four rods, which had been placed in a model patient with different levels of difficulty. For example, one rod was glued, one was broken and one was implanted in such a way that the trainee would have to order imaging. Despite following proper procedure, only seven of 15 participating surgeons successfully removed all four rods.



Language from FDA Human Factors study:

On mitigating the risks resulting from complicated removal:

-7/15 participants succeeded in removing all 4 implants. The other 8
“followed proper safety protocol.”
-1 mid-level practitioner was unable to remove all 4 implants but
proceeded to close the incision. This participant indicated that it “would be prudent to close the incision, bandage up, and send the patient for imaging to return 2-3 weeks later).
-14/15 participants correctly requested imaging studies (ultrasound or MRI) to locate non-palpable implants prior to making an incision for removal. A mid-level practitioner failed to request imaging prior to making an incision despite indicating that imaging would have been warranted. She indicated that “she would have followed that guideline in a real patient situation.” The Applicant interpreted her response as “correct” due to “study artifact.”