Welcome back CDiddy. But what advantage is ther
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Posted On: 08/28/2020 7:18:50 PM
Welcome back CDiddy.
1. The FDA indicated that they would provide a written response to CytoDyn's Type A Meeting questions by September 4. So, it is entirely possible that may have already taken place. If so, delaying the CC allows CytoDyn to tell shareholders that they have either (i) Submitted additional questions to the FDA seeking further clarification, (ii) Put the finishing touches on a revised draft of the Combo HIV BLA, or (iii) Submitted the revised draft of the Combo HIV BLA to the FDA. All of the above suggests forward progress.
2. If the FDA rejected the M/M EUA, and assuming CytoDyn preemptively drafted a protocol for a M/M Phase 3, delaying the CC would allow them to either (i) Put the finishing touches on the protocol, (ii) Submit the protocol to the FDA, or (iii) Receive approval of the protocol from the FDA. All of the above suggests forward progress.
3. Discussions with the UK MHRA may be progressing, but may not have yielded a tangible outcome. Delaying the CC allows for the possibility that they might have more to report about those discussion by Wednesday afternoon. This suggests forward progress.
4. The first paragraph in the PR states: "... provide a comprehensive update on the most anticipated timelines for multiple regulatory and clinical initiatives ..." Delaying the CC allows for the possibility of being able to announce positive updates regarding discussions with Mexico, EU, Philippines, and Israel -- or one or more other countries that they might have contacted and hope to hear back from before Wednesday afternoon. All of the above suggests forward progress.
5. Unrelated to COVID, delaying the CC possibly allows a NASDAQ uplist milestone to be achieved before Wednesday. Now, that milestone might be limited to an update on the next round of anticipated communications between the entities, or it might include a tentative approval -- which may not be actionable until a S/C EUA. In any case, this suggests forward progress.
These are some reasons why CytoDyn might delay the CC.
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But what advantage is there to delaying announcing a phase 3 by 4 days?
1. The FDA indicated that they would provide a written response to CytoDyn's Type A Meeting questions by September 4. So, it is entirely possible that may have already taken place. If so, delaying the CC allows CytoDyn to tell shareholders that they have either (i) Submitted additional questions to the FDA seeking further clarification, (ii) Put the finishing touches on a revised draft of the Combo HIV BLA, or (iii) Submitted the revised draft of the Combo HIV BLA to the FDA. All of the above suggests forward progress.
2. If the FDA rejected the M/M EUA, and assuming CytoDyn preemptively drafted a protocol for a M/M Phase 3, delaying the CC would allow them to either (i) Put the finishing touches on the protocol, (ii) Submit the protocol to the FDA, or (iii) Receive approval of the protocol from the FDA. All of the above suggests forward progress.
3. Discussions with the UK MHRA may be progressing, but may not have yielded a tangible outcome. Delaying the CC allows for the possibility that they might have more to report about those discussion by Wednesday afternoon. This suggests forward progress.
4. The first paragraph in the PR states: "... provide a comprehensive update on the most anticipated timelines for multiple regulatory and clinical initiatives ..." Delaying the CC allows for the possibility of being able to announce positive updates regarding discussions with Mexico, EU, Philippines, and Israel -- or one or more other countries that they might have contacted and hope to hear back from before Wednesday afternoon. All of the above suggests forward progress.
5. Unrelated to COVID, delaying the CC possibly allows a NASDAQ uplist milestone to be achieved before Wednesday. Now, that milestone might be limited to an update on the next round of anticipated communications between the entities, or it might include a tentative approval -- which may not be actionable until a S/C EUA. In any case, this suggests forward progress.
These are some reasons why CytoDyn might delay the CC.
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