RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:FDA IND NEWS!!!!!!!!!!!!!!!!!!Hi enriquesuave
Glad to see your comment Friday afternoon I went to a hospital to visit a friend who suffered a fine crack in her pelvis from a fall while vacationing in Jamaica which was more embarrassing then anything. So her daughter works at the clinical research facility mostly on breast cancer trials that they do for large pharma. Her daughter was visiting when I got there and she is very familiar with TLT because of me. So we discussed the trial and she said the very large hospital she worked in would need to purchase all the equipment if they were to eventually treat patients with the Theralase procedure. Now correct me if I'm wrong I told her 'no' much of the equipment you already have I said you will only have to buy the TLD-3200 (as you stated). Will hospitals need very new monitors and or special technology that is compatible to the TLD-3200?
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.