RE:Running thread to develop helpful questions for conf callI think this one was answered in the new
MD&A although more details would be helpful:
TLT met with FDA in summer 2023 and were given specific things that seem to be needed to apply and get BTD. What are those specific things? From MD&A:
"...FTD can also lead to Break Through Designation (“BTD”), Accelerated Approval (“AA”) and/or Priority Review, if certain criteria are met, which the FDA previously defined to the Company for BTD as clinical data on approximately 20 to 25 patients enrolled and provided the primary Study Procedure, who demonstrate significant safety and efficacy clinical outcomes.
To this list, the FDA has added: Post Study II Monitoring of Response and Central Pathology Laboratory Review has further defined above..."
DJDawg wrote:
We can finetune the list by Monday and then all send the same questions so that they know it is a priority. If we all send in similar questions it will be hard not to address.
Please take my draft and just add on yours and then I will try to make one master list for Monday.
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Preface to questions when we all send the list
"We are all believers in the science and want to continue to hold our shares and be investors. For many of us who have held for quite some time we need more detail on what is going on. Most recent news releases are too vague to understand what is going on. As such we request some more granularity. We want to continue to be your biggest supporters but we need more detail."
Science
If treatment so good, why hasn't a single investigator site recruited a single patient since November?
When you ask investigator sites about the nil recruitement, what feedback are they giving you?
How can you say that you anticipate recruiting 33 more patients in next 9 months if you only recruited 0 in the past 4 months?
TLT met with FDA in summer 2023 and were given specific things that seem to be needed to apply and get BTD. What are those specific things?
Summer 2023 is so long in the past, can you update us on the progress with obtaining the specific things listed from above question? Specifics please. For example, if FDA asked for longer term data on the current CR patients, what % have you been able to track down?
Finances
If science so good, why have you not been able to find a single source of funding outside of PPs?
How do you plan to raise funds to continue in the coming months, rest of year?
Other
Is progress with GBM impacted by lack of funds?
Is there likely to be any GBM phase1a announcement this year?