RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:FDA IND NEWS!!!!!!!!!!!!!!!!!!It's basically a 1 day training which is why the potential of the technology is to have the procedure as an outpatient... the device to be sold to private clinics all over north america and globally..
Yes yes.. all discussed at the 2019 AGM.
Another item to follow up on.
yawn.
lol...
enriquesuave wrote: The procedure is actually quite simple and requires minimal training IMO. TLD-1433 is instilled like BCG. A standard flexible cystoscope is used in which the fibre optic cable (DFOC) is simply inserted thru the working channel of the cystoscope. Light is switched on and the TLD-3200 system allerts the Urologist when the correct amount of light energy has been delivered. It does require training but simply in the steps involved. Every aspect of the treatment involves routinely used equipment and procedures with the only exception of the fibre optic cable and use of the new TLD-3200 system. This is not like learning a new surgical technique which requires practice,IMO after seeing one procedure and learning the steps, there is no reason for technique not to be mastered. All IMO. Dr Jewett explains this well in the AGM meeting video.
Hempdoc wrote:
Quattro74 wrote: Having that TMO agreement in the US should mean a rapid start, once IND is approved. :-)
The TMO was a necessity & should help tremendously. This treatment is definitely not your norm & certainly requires a lot more training-time than your standard & more familiar chemo/immunotherapy protocols. However, I'm not certain academic centers or other trial sites would commit their time/resources to training when a trial is on a clinical hold...unless the deficiencies are unrelated to the actual procedure? Comments would be much appreciated.