ScienceFirst wrote: Connecting the dots ... to explain some chain of events and actions.
I think that this August 2021 meeting with the FDA could have been this famous preliminary one below! TLT would have taken advantage of such option to seek guidances.
It would fit the justification behind the hiring of Dr. Vera Madzarevic after that (Oct. 25) and would then explain "her" comment on the Breakthrough designation (and how close we could be) in the Nov. 29 newsletter.
It would also explain why TLT changed its Feb. 2022 corporate presentation by identifying a period for the Breakthrough application and on advancing by 30 months its commercial revenues milestone based on guidance by the FDA.
It would also support the action of Roger and Kristina to invest their own money in regards to the warrants as they would have received some kind of guidance on what the FDA likes about our drug, what's coming, what are our chances, etc ....
We're on solid ground.
Can a sponsor get preliminary breakthrough therapy designation (BTD) advice from the review division prior to the submission of a formal BTD request?
A sponsor can contact the regulatory project manager (RPM) in the division to which the active IND is assigned and request the “Preliminary Breakthrough Therapy Designation (BTD) Advice Request” template. This template should then be submitted as a formal amendment to the IND and a subsequent teleconference between the sponsor and the review division will be set-up by the RPM. The review division will make a recommendation as to whether a request for a BTD is appropriate, may be too preliminary, or does not currently meet the criteria for a BTD. The Agency’s recommendation is advisory and is not to be interpreted to predict the Agency’s decision on the BTD request. NOTE: A Preliminary BTD Advice Request may be submitted to an active PIND, although a formal BTD request may not be submitted until the IND is opened.