RE:RE:RE:RE:RE:RE:RE:RE:What could move share price upward?Hempdoc wrote:
tdon1229 wrote: Macer,
Thank you for the dose of reality. You might have added that the data is not in the hands of the company until the Primary Investigator releases it to them. Nor can it be published until the PI says okay. The PI has the responsibility for gathering the data, analyzing it, and ultimately publishing it.
Any onesy and twosy interim results are simply not statisically meaningful in a clinical trial for durable efficacy, especially one with as many variables as this one has: a new laser device, a computerized optimizing routine, new photosensitizer, new procedure, multi-site investigation for reproducibility, etc. No wonder the FDA is taking so long getting up to speed. Besides, very little gets done or decided by the bureaucracy from the beginning of December through the middle of January. Even without a government shutdown, the government virtually shuts down.
Neither are onesy and twosy results considered material information, unless maybe patients are experiencing severe adverse effects. Stockholders and blog commentators don't get to define the hoops the company must jump through to satisfy their individual wants and desires.
The company is just the sponsor of the cllinical trial. They're not conducting the trial themselves or with their own employees. Therefore, the company must remain at arm's length to avoid the human tendency to pump the results and profit from inflating the stock price. At least, that's how I understand it's supposed to work.
Regards,
TDON1229
Please chime in if I'm wrong, but it is my understanding that the consents signed by patients will determine the "timing" of sharing trial data with the sponsor or the public. If a participant agrees to the sharing of his data at anytime, that data can be shared in an announcement at anytime....knowing very well that an announcement of interim results in a smaller number of patients is never meant to make any claims or projections about efficacy or an expected outcome...they are simply data points yet to be published.
Being an early Ph 2 clinical trial, it's a given that statistical significance for approval has yet to be reached, but drawing "closer" to significance has a lot more meaning/ramifications for those who want to have another option or chance of preserving their bladders & lives. The decision should clearly & always be in the patients' hands, & not those of any doctor or bureaucrat. JMHO
It is highly unlikely that patients factor into the timing of the outcomes reporting. Most of them could care less apart from their own outcome. The REB agreement clearly outlines the manner in which data is shared and managed. To my knowledge as long as it remains de-identified anything goes. This is why I found it suprising that dates of treatment were published.
either way, apart from the pop in the SP that would occur with publishing a 100% CR rate at 90 days I don't really care to here about outcomes until 6 months. IND and more clinical sites Treating patients is what will drive this up more sustainably
Macer