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Posted On: 02/20/2022 6:15:31 AM
Post# of 148878
Dear new CYDY board:
I wanted to, respectfully, submit the following questions:
At the onset of 2022 we had some results on the 350mg P2 NASH trial which yielded statistically significant results for primary end point for both ITT (intent to treat) and PP (per protocol); and secondary endpoint for PP (p=0.02); for ITT was 0.057, slightly above. These, imo are excellent results
We were at the time sharing the data and talking to other countries and “over 3 fingers” pharmaceuticals all over the world
QUESTION: Have these talks produced any results?
Also, the results for the 700mg NASH trial should be by now fully tabulated and analyzed.
QUESTION: Were the results as good as those for 350mg?, and if so: have we filed for BTD and are the results helping in securing a world-class partnership to undertake a fail-safe P3 trial?
In January of this year, we reported for 28 patients with mTNBC an overall survival (OS) of 12.5 months; the median with Sacituzumab is 12.1 months. Since it took about 2 months for FDA to submit the BTD response and about a month to tabulate the data, currently we are around 6 months further with our patients.
QUESTION: Are the patients alive? If so, having superior data to SC, are we submitting and update and new application for BTD to FDA (pointing out as well that, apart from superior OS, Leronlimab poses no adverse effects as opposed to Trodelvy?).
The FDA has allowed us to do meta-analysis in our double-blinded placebo-controlled COVID trial, also, reportedly, as of end of 2021 we needed 15 more patients or so (having 62) to perform an interim analysis.
QUESTION: Do we have more data form Brazil? Are or have we performed an interim analysis? What are the results??
I would like to respectfully point out that any positive news that, no doubt you are privy of, once made public, will increase swiftly the SP to well above one finger, if not two fingers, which would facilitate, to a great extent, your current (and very important) effort to strengthen our company finances.
TechGuru
I wanted to, respectfully, submit the following questions:
At the onset of 2022 we had some results on the 350mg P2 NASH trial which yielded statistically significant results for primary end point for both ITT (intent to treat) and PP (per protocol); and secondary endpoint for PP (p=0.02); for ITT was 0.057, slightly above. These, imo are excellent results
We were at the time sharing the data and talking to other countries and “over 3 fingers” pharmaceuticals all over the world
QUESTION: Have these talks produced any results?
Also, the results for the 700mg NASH trial should be by now fully tabulated and analyzed.
QUESTION: Were the results as good as those for 350mg?, and if so: have we filed for BTD and are the results helping in securing a world-class partnership to undertake a fail-safe P3 trial?
In January of this year, we reported for 28 patients with mTNBC an overall survival (OS) of 12.5 months; the median with Sacituzumab is 12.1 months. Since it took about 2 months for FDA to submit the BTD response and about a month to tabulate the data, currently we are around 6 months further with our patients.
QUESTION: Are the patients alive? If so, having superior data to SC, are we submitting and update and new application for BTD to FDA (pointing out as well that, apart from superior OS, Leronlimab poses no adverse effects as opposed to Trodelvy?).
The FDA has allowed us to do meta-analysis in our double-blinded placebo-controlled COVID trial, also, reportedly, as of end of 2021 we needed 15 more patients or so (having 62) to perform an interim analysis.
QUESTION: Do we have more data form Brazil? Are or have we performed an interim analysis? What are the results??
I would like to respectfully point out that any positive news that, no doubt you are privy of, once made public, will increase swiftly the SP to well above one finger, if not two fingers, which would facilitate, to a great extent, your current (and very important) effort to strengthen our company finances.
TechGuru
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