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Posted On: 11/05/2020 11:16:39 PM
Post# of 148881
Couple of miscellaneous observations:
1. There has been quite a bit of discussion regarding the FDA having eyeballs on the Interim-195. I obviously don't have empirical knowledge regarding anything around that topic, but it is an incontrovertible fact that Dr.NP occasionally provides ambiguous or inaccurate information.
Notwithstanding, Dr.NP has very clearly (and repeatedly) claimed that there will be no opportunity for a COVID EUA or Approval, from any country, prior to the unblinding of the Interim-293. That's a statement that I take at face value.
It is human nature to try to connect dots in order to arrive at a desired conclusion. However, I believe it is a mistake to arrive at a desired conclusion on the basis of potentially imperfect information.
2. I enjoyed hearing about the conversation that took place with OWS and Dr.NP stating that Lonza will be involved (along with Samsung)
"... if we need to ..." (Timeline: 1:24:00)
This reference possibly suggests that OWS inquired about how to increase leronlimab production on an accelerated basis. It was a bit odd that Dr.NP did not mention AGC, however to-date they have only been responsible for small batch production used in the clinical trials. And their new large batch bioreactors are slated to open in April in Boulder, Co and would probably need to go through an extensive approval process.
3. It was interesting to hear that Dr. Harish Seethamraju would be leading the new Scientific Counsel. While watching his video presentation around a month ago, I was really struck by how frequently he referred to CytoDyn/leronlimab using the pronoun of "we" and "our". That linguistic usage makes quite a bit more sense to me now.
4. The reproductive and pediatric studies required by UK MHRA, whether CytoDyn receives a waiver or not, have caused me to re-calibrate my notion of when we might receive UK approval. Similarly, the 4+ months estimated for the FDA-requested Receptor Occupancy tests is also a potential concern, especially because CytoDyn has still not learned if the FDA will allow for a staggered submission of that RO data.
1. There has been quite a bit of discussion regarding the FDA having eyeballs on the Interim-195. I obviously don't have empirical knowledge regarding anything around that topic, but it is an incontrovertible fact that Dr.NP occasionally provides ambiguous or inaccurate information.
Notwithstanding, Dr.NP has very clearly (and repeatedly) claimed that there will be no opportunity for a COVID EUA or Approval, from any country, prior to the unblinding of the Interim-293. That's a statement that I take at face value.
It is human nature to try to connect dots in order to arrive at a desired conclusion. However, I believe it is a mistake to arrive at a desired conclusion on the basis of potentially imperfect information.
2. I enjoyed hearing about the conversation that took place with OWS and Dr.NP stating that Lonza will be involved (along with Samsung)
"... if we need to ..." (Timeline: 1:24:00)
This reference possibly suggests that OWS inquired about how to increase leronlimab production on an accelerated basis. It was a bit odd that Dr.NP did not mention AGC, however to-date they have only been responsible for small batch production used in the clinical trials. And their new large batch bioreactors are slated to open in April in Boulder, Co and would probably need to go through an extensive approval process.
3. It was interesting to hear that Dr. Harish Seethamraju would be leading the new Scientific Counsel. While watching his video presentation around a month ago, I was really struck by how frequently he referred to CytoDyn/leronlimab using the pronoun of "we" and "our". That linguistic usage makes quite a bit more sense to me now.
4. The reproductive and pediatric studies required by UK MHRA, whether CytoDyn receives a waiver or not, have caused me to re-calibrate my notion of when we might receive UK approval. Similarly, the 4+ months estimated for the FDA-requested Receptor Occupancy tests is also a potential concern, especially because CytoDyn has still not learned if the FDA will allow for a staggered submission of that RO data.
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