RE:RE:the protocol change notice from Health CanadaLegit62 wrote: My thought on this is that this shouldnt affect our BTD or AA timing, since we already have the patients needed for that and they were just going to resubmit another pre BTD approval, Correct??? Im still optimistic for late 4TH q 23 or 1ST q 24 with possible JV news soon after that
Legit62...You are correct this new protocol will not affect the pre-BTD & BTD application.
For now this new protocol has only been approved for Canadian patients. In order for this new protocol to apply to US patients TLT would have to first receive a letter of approval from the FDA Institutional Review Board(IRB) (Google it).
For now the pre-BTD & BTD application follow its normal course.
Note:
In the Oct 16,2023 Pressrelease R.Dumoulin(TLT CEO) said " Theralase is
investigating potential partnership for commercialization financing and distribution of this ACT technology on an international basis."
It is the first time that TLT is using a word(
investigating) that indicate that Dr Lbiati has seriously started to look for a partner.
Needless to say that the deal will be conditional to the FDA approval of TLT- Ruvidar.