Why so long for the FDA approvalI don't see much point in contacting the company as I don't anticipate that I would learn anything different than what the company has already told people. But one wonders why the FDA is taking so long for approval. We already know that the treatment is safe and well tolerated with some minor side effects. One would think that at the stage that TLT was at that an expert in submitting submissions for clincial studies to the FDA would have had TLT's submission approved from the FDA and not have it put on hold and still waiting 3 months later...coming up 4 months...
Hope they get it approved this month. Had the original submission to the FDA been approved last year, we would be well on our way in the USA with patients treated. Now unfortunatley for all, COVID-19 could affect this delayed US FDA approved trial in a variety of ways.
Here's to hoping that the FDA approval comes in this month. Will be very interesting to see results over the next months of the patients treated in Canada.