RE:RE:Next 90 Day Time ClockThat's what I was thinking too Eoganacht and I'm sure I needn't tell you that with BTD even with the first 12 being underdosed that the Ph2 study (I believe but could be wrong) has to demonstrate a marked improvement during the study towards higher CR and with that a very strong chance of BTD. Should Theralase receive that designation not only will the Anti Cancer Therapy start making profit from this procedure but also the Cool Laser department will be getting orders from hospitals for lasers in both Canada & USA. Now I'm not too familiar with European regulations but I would think they wouldn't be that different than ours so perhaps within a year sales can be realized there too.
Eoganacht wrote
Thanks for that 99942Apophis. If they are on track with patient #25 his/her 90 days should be by the end of Dec. If I understand correctly they'll apply for Breakthrough Therapy Designation and Accelerated Approval one year later - the end of Dec 2022. If we get priority review from the FDA they will make their decision within 6 months. So, if all goes well, Theralase may be allowed to commercialize TLD1433 as a treatment for BCG refractory NMIBC by the end of June 2023. 99942Apophis wrote: Patient # 19 news release dated May 28 = 90 day Mid Sept
Patient # 20 news release dated June 11 = 90 day End Sept
Patients # 21 - 24 news release dated Aug 30 = 90 day Mid Dec
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