Posted by TC on Finance yahoo: Summary of today's conference call.
Today’s call w/ mgmt…
CFO, CEO, CBDO, CTO, SVP Clinical Ops for CRO (Amarex) attending.
NP
- Explaining letter from FDA about BLA (RTF letter)
- 2018 hit endpoints
- 2019 agreed with FDA on rolling review on higher dose 700 mg dose and FDA wanted monotherapy trial to enroll on 700 mg dose, which they achieved by October 2019
- CYDY felt application was completed for BLA
- Agency felt application not complete (RTF letter) which provided detailed information (clear information) about what is needed to cure the problem
- Have opportunity for TypeA meeting to reach alignment with FDA
- FDA used great detail about what they need, and CYDY will work on quickly and without trial (to reach detail they require)
- Confident in a position to get the FDA what they need. This will be a minor set back. They mostly need things for 1 module of clinical and a few minor things in manufacturing filing.
Dr. N. Ray update on manufacturing
- Nobody in the world is more familiar with manufacturing this.
- He will speak to the RTF on manufacturing
- The FDA is not related to product but rather the devices they propose in the commercial packaging. FDA wants name of manufacturers of needles, syringes and test done was missing supposedly, but it was there in two sections. The manuf. of syringes and needles are inserted in their original packages and inserted into the CYDY commercial packaging. They need to understand this. This is self-injection at-home, so the information is on the original manufactures packages, and the FDA missed this.
Dr. Kush Dotie (sp?)
- From the CRO. Clinical section comments. Critical components is related for the fact that they are looking for 700 mg dose which was tested in the Monotherapy trial. Whereas the trials in multi-product for heavily treated patients was for 350 mg dose. FDA was additional analysis to be performed on the ongoing CD-03 trial which is trialing both 350 mg dose vs. 700 mg dose for an integrated comparison of efficacy and safety. Have completed all the treatments for all 500 subjects in the study. So we are in a strong position to address all the comments from the agency. Ongoing patients only in the follow-up. Initial study ended in June 2020, and all the items are available to be provided to the FDA.
- Non-Clinical – no comments
- Manufacturing – comments about syringes
- Clinical – need comparison of doses analysis
Unblind data in CD10 this week – most likely Thursday or Friday. Announce results next week once bio-statisticians done with their review.
Dr. Kelly – licensing partnering etc. Talking to 5 worldwide pharma companies as well as companies in Brazil, Middle East, Africa and Asia.
Dr. Brown was the first practitioners to reach a cure. Hoping to use Leron with patient with HIV patient with cancer getting a bone marrow transplant in order to cure the HIV.
CFO – working diligently on uplifting. Earlier today, completed submission of multi-part application for NASDAQ. CYDY raised $50M in first 6 months. $42M has come from warrants. $12M in warrant exercises in June alone.
No issue on $4 stock at uplist time – no problem
On $3 stock price at time of uplist – still meet the net tangible asset standard
Today’s call w/ mgmt…
CFO, CEO, CBDO, CTO, SVP Clinical Ops for CRO (Amarex) attending.
NP
- Explaining letter from FDA about BLA (RTF letter)
- 2018 hit endpoints
- 2019 agreed with FDA on rolling review on higher dose 700 mg dose and FDA wanted monotherapy trial to enroll on 700 mg dose, which they achieved by October 2019
- CYDY felt application was completed for BLA
- Agency felt application not complete (RTF letter) which provided detailed information (clear information) about what is needed to cure the problem
- Have opportunity for TypeA meeting to reach alignment with FDA
- FDA used great detail about what they need, and CYDY will work on quickly and without trial (to reach detail they require)
- Confident in a position to get the FDA what they need. This will be a minor set back. They mostly need things for 1 module of clinical and a few minor things in manufacturing filing.
Dr. N. Ray update on manufacturing
- Nobody in the world is more familiar with manufacturing this.
- He will speak to the RTF on manufacturing
- The FDA is not related to product but rather the devices they propose in the commercial packaging. FDA wants name of manufacturers of needles, syringes and test done was missing supposedly, but it was there in two sections. The manuf. of syringes and needles are inserted in their original packages and inserted into the CYDY commercial packaging. They need to understand this. This is self-injection at-home, so the information is on the original manufactures packages, and the FDA missed this.
Dr. Kush Dotie (sp?)
- From the CRO. Clinical section comments. Critical components is related for the fact that they are looking for 700 mg dose which was tested in the Monotherapy trial. Whereas the trials in multi-product for heavily treated patients was for 350 mg dose. FDA was additional analysis to be performed on the ongoing CD-03 trial which is trialing both 350 mg dose vs. 700 mg dose for an integrated comparison of efficacy and safety. Have completed all the treatments for all 500 subjects in the study. So we are in a strong position to address all the comments from the agency. Ongoing patients only in the follow-up. Initial study ended in June 2020, and all the items are available to be provided to the FDA.
- Non-Clinical – no comments
- Manufacturing – comments about syringes
- Clinical – need comparison of doses analysis
Unblind data in CD10 this week – most likely Thursday or Friday. Announce results next week once bio-statisticians done with their review.
Dr. Kelly – licensing partnering etc. Talking to 5 worldwide pharma companies as well as companies in Brazil, Middle East, Africa and Asia.
Dr. Brown was the first practitioners to reach a cure. Hoping to use Leron with patient with HIV patient with cancer getting a bone marrow transplant in order to cure the HIV.
CFO – working diligently on uplifting. Earlier today, completed submission of multi-part application for NASDAQ. CYDY raised $50M in first 6 months. $42M has come from warrants. $12M in warrant exercises in June alone.
No issue on $4 stock at uplist time – no problem
On $3 stock price at time of uplist – still meet the net tangible asset standard
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