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Posted On: 10/03/2022 10:30:06 AM
Post# of 148870
PBio with an interesting post on expectations set up by the conference call:
PBio8 minutes ago
"I wanted to share my expectations (not predication!) based on the historical data, current CC, and my pharma experience:
1. Warning Letter: Cytodyn confirmed that they have recently completed the warning letter close-out process with FDA. Once the FDA has reviewed their response and found it acceptable, we MAY get some kind of confirmation from the management.
2. Clinical Hold: Cytodyn also confirmed that they believe that they now have the required data from Amarex to address the FDA's concerns and have the first of a series of docs that are in line for submission to the FDA. Based on this confirmation, I am giving CYDY by the end of October to complete the remaining items.
3. HIV BLA Submission:
1. CYDY has started the internal GCP audit for Amarex to confirm the acceptability of the data (A standard practice in the pharma industry). They also confirmed that "this audit is not a question of the performance of Leronlimab in clinical trials. Rather, it is an assessment of the quality of the data collection and monitoring performed by Amarex." I estimate that CYDY will receive the audit report in the next few weeks, which will require some kind of remediation at Amarex. Based on this assumption, I am targeting the end Nov or December for the filing of the clinical section of BLA.
2. FDA is already doing the rolling review of non-clinical sections. I assume that CYDY has begun receiving comments from the FDA and may respond to them expeditiously. As the product is being manufactured at Samsung Biologics, the best manufacturing facility for Biotech products, I do not expect any significant comments from FDA regarding the non-clinical sections.
3. If CYDY submits the last section of BLA by Nov/Dec, our PDUFA date will be May/June 2023. However, as FDA has been doing the rolling review, I expect the review to be completed in four months instead of the standard six months review cycle. Therefore, the potential approval date could be March/April 2023 if everything falls in place.
4. Partnership:
1. I am very sure that all the potential partners have had access (after signing the NDA) to the non-clinical portion of HIV, which was submitted to the FDA earlier. This is a very critical point to understand. As most of the current big biotech companies make their product at Samsung, they are already aware of the quality standards at this manufacturing location. They may also have access to the feedback from FDA as part of the rolling review. As I mentioned earlier, once we get approval for HIV, all subsequent filings for any indication will require only the clinical sections to be submitted. This is a massive advantage for any company. Any potential partner to conduct their clinical studies can be assured approval if the clinical data is acceptable.
2. I estimate that any partnership agreement will be reached ONLY after we have submitted our BLA. Therefore, we can expect PR within 4-8 weeks of submitting BLA – around Jan/Feb.
In summary: If lifting of clinical hold is T0, then BLA filing will be T+1 Month, approval T+ 6 months, and partnership within T+2 months."
PBio8 minutes ago
"I wanted to share my expectations (not predication!) based on the historical data, current CC, and my pharma experience:
1. Warning Letter: Cytodyn confirmed that they have recently completed the warning letter close-out process with FDA. Once the FDA has reviewed their response and found it acceptable, we MAY get some kind of confirmation from the management.
2. Clinical Hold: Cytodyn also confirmed that they believe that they now have the required data from Amarex to address the FDA's concerns and have the first of a series of docs that are in line for submission to the FDA. Based on this confirmation, I am giving CYDY by the end of October to complete the remaining items.
3. HIV BLA Submission:
1. CYDY has started the internal GCP audit for Amarex to confirm the acceptability of the data (A standard practice in the pharma industry). They also confirmed that "this audit is not a question of the performance of Leronlimab in clinical trials. Rather, it is an assessment of the quality of the data collection and monitoring performed by Amarex." I estimate that CYDY will receive the audit report in the next few weeks, which will require some kind of remediation at Amarex. Based on this assumption, I am targeting the end Nov or December for the filing of the clinical section of BLA.
2. FDA is already doing the rolling review of non-clinical sections. I assume that CYDY has begun receiving comments from the FDA and may respond to them expeditiously. As the product is being manufactured at Samsung Biologics, the best manufacturing facility for Biotech products, I do not expect any significant comments from FDA regarding the non-clinical sections.
3. If CYDY submits the last section of BLA by Nov/Dec, our PDUFA date will be May/June 2023. However, as FDA has been doing the rolling review, I expect the review to be completed in four months instead of the standard six months review cycle. Therefore, the potential approval date could be March/April 2023 if everything falls in place.
4. Partnership:
1. I am very sure that all the potential partners have had access (after signing the NDA) to the non-clinical portion of HIV, which was submitted to the FDA earlier. This is a very critical point to understand. As most of the current big biotech companies make their product at Samsung, they are already aware of the quality standards at this manufacturing location. They may also have access to the feedback from FDA as part of the rolling review. As I mentioned earlier, once we get approval for HIV, all subsequent filings for any indication will require only the clinical sections to be submitted. This is a massive advantage for any company. Any potential partner to conduct their clinical studies can be assured approval if the clinical data is acceptable.
2. I estimate that any partnership agreement will be reached ONLY after we have submitted our BLA. Therefore, we can expect PR within 4-8 weeks of submitting BLA – around Jan/Feb.
In summary: If lifting of clinical hold is T0, then BLA filing will be T+1 Month, approval T+ 6 months, and partnership within T+2 months."
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