NP said today that CYDY is planning to meet with F
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Posted On: 07/22/2020 7:26:51 PM
NP said today that CYDY is planning to meet with FDA in September for BTD for cancer (mTNBC). He said that there are currently 15 patients in the mTNBC trial with another 12 pending.
Once there are 18 patients enrolled in the mTNBC trial, the phase 1b portion of the trial will be completed in the following weeks. That means the phase 2 trial can start shortly after, with the the maximum tolerated dose of leronlimab (most likely 700mg) combined with the SOC. That’s a 30 patient trial. I hope that we get a press release soon or around full enrollment of the phase 1b and that the PR has an update on CTCs, CT scans, etc.
In regards to the BTD meeting for cancer, I’m assuming CYDY is planning on submitting the data (CTCs, CT scans, etc.) from the 18 patients in the phase 1b trial. They can also add data from any patient(s) with mTNBC from the compassionate use trial to the application as well. If the data is clear, I don’t think the FDA can deny BTD, especially when considering nearly zero side effects with addition of the leronlimab.
I’ve said it before and I’ll say it again: I believe cancer will be the biggest indication for leronlimab and that’s why I heavily invested in 2019 (after starting a smaller position in 2018). Now that the scientific advisory board has a few oncologists, I hope enrollment sites and enrollment pace will pick up like COVID did after doctors were made more aware of the drug.
Once there are 18 patients enrolled in the mTNBC trial, the phase 1b portion of the trial will be completed in the following weeks. That means the phase 2 trial can start shortly after, with the the maximum tolerated dose of leronlimab (most likely 700mg) combined with the SOC. That’s a 30 patient trial. I hope that we get a press release soon or around full enrollment of the phase 1b and that the PR has an update on CTCs, CT scans, etc.
In regards to the BTD meeting for cancer, I’m assuming CYDY is planning on submitting the data (CTCs, CT scans, etc.) from the 18 patients in the phase 1b trial. They can also add data from any patient(s) with mTNBC from the compassionate use trial to the application as well. If the data is clear, I don’t think the FDA can deny BTD, especially when considering nearly zero side effects with addition of the leronlimab.
I’ve said it before and I’ll say it again: I believe cancer will be the biggest indication for leronlimab and that’s why I heavily invested in 2019 (after starting a smaller position in 2018). Now that the scientific advisory board has a few oncologists, I hope enrollment sites and enrollment pace will pick up like COVID did after doctors were made more aware of the drug.
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