RE:RE:Well I guess we can forget about...digitel wrote: It looks like they believe they can address the deficiencies with the FDA in less than one month in a letter. This sounds like minor details which is probably why it is being presented more as a footnote as opposed to a news release earlier in the week. I don't see TLT saying they require more testing, etc., just some paperwork. FDA approval can happen in early 2020 and we are only one month from that starting.
"FDA IND Status. On November 25, 2019, Theralase received a letter from the FDA placing the IND on Full Clinical Hold pending resolution of specific deficiencies identified in the letter. Theralase is currently addressing these deficiencies and expects to provide the FDA with a Clinical Hold Complete Response prior to December 31, 2019 for review by the FDA. Subject to FDA review and approval of the Clinical Hold Complete Response, Theralase should be in a position to receive FDA IND approval in early 2020."
Read more at https://stockhouse.com/news/press-releases/2019/11/29/theralase-releases-third-quarter-2019-financial-results-and-company-update#aK2717Z4tQvsQPfi.99
This was my interpretation as well.
I have learned to ignore the "sky is falling types" like bluemental before I even finidh reading the posts. Health Canada is much more stringent than the FDA. If it is pased here there willnot be a problem in the US. I must say that dealing with US goverment agencies being a foreigner can be rather challening.
I had the pleasure of having taxes taken from me on money that I had made in the US. I had to file a tax return in the US in order to get it back. They did not help me one bit in trying to get that done. it took me over a year to navigate.
I think Theralase is doing just fine.
Relax and chill, it's the weekend
Macer