The VERY slow process of getting module 2 and module 3 to the FDA for the PMA is quite alarming.. No updates-No confirmation it was actually sent to them. It is nice tha the NCI approves this device but the only approval that matters is the FDA.... Also,there seems to be a shift in the device's use. It was first thought as> a ''Replacement for the Pap Smear' Now it may not be used in conjuction with the Pap Smear,but instead with Coloscopy,which is a much smaller market. Very Strange' And what happened with the CE approval? Was it even submitted for consideration in Europe?
Submission of modules, etc. to the FDA is a notoriously slow process and should not be used as an indicator of success or failure. The device will likely be a replacement for the pap smear but in the beginning it may be used in conjunction with the pap smear by conservative doctors who have been using pap smear for more than 30 years and who want to compare results. The indication has not changed. Colonoscopy is an exciting potential indication, which does not in any way replace the device's cervical cancer screening application. It will take longer to develop applications in colonscopy because a lot of data will have to be collected before specific indications within the field can be accepted.
Colposcopy I meant- I think Company is shying away from main use with Pap Smear and more with Colposcopy ,which is used when pap smear shows a problem..This decreases market value.. The FDA process is slow in evaluating devices but that has nothing to do with the the Company NOT submitting the full PMA application.What is Guided Therapeutics excuse for this prolonged delay? -The Light Touch pre-clinical module was submitted 2 years ago! FDA awaits the Clinical and Manufacturing module of the Device and until then Light Touch will not be approved. FDA has NOT received module 2 and module 3 >though Company has made promises for almost 2 years now...., thats my Concern.