RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Optimal endobronchial tool sizes for targeting lung lesionsInvestclub ... Not sure that TLT will publish interim
data on p#1 of the Ph. 2b. But that would be interesting.
In the Ph. 1b, there was only one site (PMCC). Now there will be 4 canadian sites + between 4 to 6 major US sites in the short-term to treat between 25-50 US patients (with an overall longterm number of expected sites to be around 20).
My take is that TLT will wait for collect 3-month data on more patients before publishing data. Will they want to make it an all canadian story first, will they want to have a mixture of US and canadian patients data because of the important visibility they could get in the US, that is up to anybody's call and will most probably also depend on how striking is the data, to make this statistically significant. Their decision will most probably also be based on how many the FDA wants to see in order for example to apply for potential breakthrough-type of designations. The FDA also requires that your data comes from a variety of geos, groups of age, ethnicities, etc ... Maybe not for the 3-month data but for sure for the 12-month data ... I remember that a competitor was toasted 3 years ago by the FDA panel when they were seeking FDA approval for its NMIBC commercial rights.
As per Jojomarch's recent post:
July 24, 2019 ... is pleased to announce that the Company has signed an agreement with a Trial Management Organization (“TMO”) to provide 4 to 6 US based urology study sites that will be able to commence enrolling and treating patients, subject to Food and Drug Administration (“FDA”) Investigational New Drug (“IND”) approval for its Phase II Non Muscle Invasive Bladder Cancer (“NMIBC”) Clinical Study (“Study II”). The TMO is in discussions with approximately 14 potential US based clinical study sites that are large integrated clinical urology practices. The TMO’s mandate is to expeditiously complete clinical studies in uro-oncology. Each of these individual clinical study sites has a dedicated and robust clinical infrastructure that is lead by experienced principal investigators and clinical research co-ordinators. The TMO has a highly structured approach to executing and managing clinical studies, which allows a rapid enrolment and treatment of patients according to clinical protocols. ... In conjunction with this TMO and its network of clinical study sites, Theralase will select 4 to 6 clinical study sites that could potentially enroll and treat between 25 to 50 of the approximately 100 patients the Company is expecting to recruit and treat in its Phase II Clinical Study, subject to US FDA IND approval. This agreement greatly assists our US study site onboarding and patient enrollment as the Company prepares to file the IND application and negotiate onboarding additional study sites with other organizations in the US”. Through the lengthy process of identification and selection of clinical study sites, I am pleased to mention that our clinical study co-ordinators and myself are diligently working on finalizing 4 additional sites in Canada, 5 in the US (in addition to the TMO study sites) and 5 in Europe The Sept. 04 news was to identify the official launch of Ph. 2b:
September 04, 2019
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investclub - (10/30/2019 10:09:26 AM)
RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Optimal endobronchial tool sizes for targeting lung lesions Hi StevenBirch if Theralase hasn't any feedback from the FDA then wouldn't you think with only one day to go it's a done deal. Maybe I'm a little premature but I think this is a significant milestone that TLT is crossing over! Next major after this will be the Dec release of patient#1 for PH2 ...