RE:RE:RE:RE:Large down gaps, monthly chart 2019 July & Augustfloatinketucky wrote: At the closing of the phase one study buyers were looking for the next buisness devlopment and it was a long ways out. The price fall began in March. Other investers soon realized how far out the next signifigant steps would be taken for Phase 2 Pivitol. And the market forces propelled.
The market forces are again propelling in the opposite.
Then phase 2 patients were undertreated sigfifigantly..
July 30, 2 Study Treatment Optimizations:
Additional optimizations to the clinical study protocol that have been implemented for all future patients to be enrolled and treated in Study II and for the five patients yet to receive their second treatment, include:
Bladder Volume Calculation:
The clinical protocol did not clearly define the bladder volume calculation to be used by the pharmacy and the principal investigator to determine bladder size for administration of the Study Drug and Study Device, respectively. Average bladder volume voided over a 3 day period was used as opposed to a percentage of the maximum bladder volume voided.
Study Device Treatment Time:
The Study Device treatment time was based on detected bladder irradiance, which varied dramatically inside patient bladders due to shape, volume and bladder wall reflection. This led to undertreatment of certain patients with the Study Device by up to 87.9%. This has been modified to now determine Study Device treatment time based solely on the new bladder volumecalculation, resulting in a more consistent Study Device treatment time across patients.
Summary:
The total of these Study II variances (Study Drug Volume, Study Device Volume and Study Device Treatment Time) have led to all 12 patients being undertreated by the Study Treatment from between 30.9% and 154.3%.
Theralase Reports on Phase II Non-Muscle Invasive Bladder Cancer ("NMIBC") Clinical Study ("Study II") Progress (accesswire.com)