RE:BTD is slow process. In order to get a BTD a company must demonstrate substantial improvement over available therapy. Adstiladrin was approved by the FDA in Dec. 2022. 18 month evaluation of patients was built into their trial. When Theralase spoke to the FDA about how to optimize their chances of getting BTD they may have been told that to demonstrate substantial improvement over Adstiladrin they needed to show a better durable response at 18 months. Unlike the Adstiladrin trial, an 18 month assessment was not part of the protocol for the Ruvidar PDT trial. Theralase had to scramble to change their protocol and get the data.
The FDA may not even have asked for the 18 month data. They may have just suggested that, as well as better 15 month data, presenting substantially better 18 month data would go a long way in proving s better durable response than the best available therapy and thus improve Theralase's chances of a successful BTD application.
Likewise, to get an AA a company must show their therapy fills an unmet medical need. The best way to prove this is to show definitively better efficacy and durability of response than existing therapies.
DJDawg wrote: In recent updates or intervies (I can't remember), RDW said that they met FDA in July and got the info that they needed to clarify some of the data. Most of you would agree that it seems to be taking forever to clarify whatever it is that needs clarity. It would be nice for RDW to enlighten the shareholder a bit more regarding what they are gathering. It all seems so vague.
The fact that the wording is "clarification" makes one think they want additional data on existing patients vs some other wording that would suggest more patient numbers needed.
In the past my speculation was that the FDA wanted 18 m data outcomes but I really don't know for sure. My guess was based on the update that they were seeking Health Canada approval to chase down outcomes on the CR patients from day 450.
"Post Study II Monitoring of Response - Patients, who achieved a Complete Response ("CR") or Indeterminate Response ("IR"), demonstrated a duration of that response at 450 days and remained in Study II will be monitored by the Company past 450 days, to help define the long-term duration of the Study II Treatment."
My thought was that why do then need to chase it down unless someone's asking for it. If they didn't build that in the protocol then it means they have to go to each location where the 17 CR's at 450 are from and request ethics ammendment to get any data past 450 days. Totally doable but slow if you know anything about research ethics.
I have noticed that several of the other big studies have emphasized that their CR's are confirmed by a central lab. So that would be the other thing. You would need to get the slides with the cells from cytology and then ship them to your one designated pathologist. Not hard to do but takes a bit of time. Thankfully it is probably only needing to be done on CR or IR at 450 day patients.
I've said this before, I'm just talking aloud in case anyone has any other idea what "clarity"
But they met with FDA in July. You would think that they could have done all this by now. So frustrating.
One day I would love for TLT to suprise us all in a really good way. Something happening sooner than expected or some JV money that is announced out of the blue or an uptick in recruitment. I would love for something that is a real "wow" moment from management. The science is so amazing but TLT so slow to progress it.
If management is reading these forums we would love more info on what is being clarified and why that takes so long.