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Posted On: 05/19/2021 12:02:36 PM
Post# of 149007
This from a bureaucrat perspective, not me, posted on the other board:
I've been wanting to add my perspective as a long-time regulatory professional after seeing the statement from FDA yesterday, hearing doom and gloom summaries of the CC from various naysayers, and then listening to the CC myself. TL
R summary = I thought the call went very well given the circumstances, and things still seem to be on track.
First and foremost I was impressed with the unified, conciliatory and friendly tone of CYDY management towards FDA, which must have been a challenging position to take after the events of yesterday. This means they are clearly focused on moving forward with US FDA, and that they are not willing to indulge in conspiracy theories of BP/FDA corruption and other distractions which (whether true or not) are just that - distractions. If Nader and CYDY management ever decide to start indulging such distractions and stop focusing on making forward progress, I will promptly sell all of my shares.
The tone and content of the FDA statement from yesterday was consistent with many I have read before in confidential correspondence with them. The only reason I can think that it was published on FDA's website is that they must have been facing overwhelming public advocacy for Leronlimab, and clearly some of it (probably a lot of it) was from people who are misinformed. Some of this can be fairly blamed on the hyperbole of CYDY executive management, which I've unfortunately found to be ubiquitous among small biotech C-suites; however, some blame must also go to FDA, who has made a number of high-profile blunders and questionable approvals throughout this pandemic. Regardless, over the years I have regularly had to reassure stakeholders that FDA is simply incredibly risk-averse, and their written correspondence should not be taken personally. It is unfortunate that their statement was made publicly available to shareholders at large, who have clearly over-reacted given that no new information was shared with us.
Finally, the clarity Nader provided on their move overseas makes perfect sense in the context of drug development: if you live in a country where there are no patients in your intended treatment population (i.e. severe COVID), you must go overseas to enroll patients. It had nothing to do with FDA asserting that there was no path forward for Leronlimab. This was a straightforward and sensible answer to my main question of what precipitated the move overseas, and whether it had to do with bad blood here in the US.
In sum: I'm not surprised by the FDA letter, although I feel its publication was unfair to CYDY shareholders. However, life is often unfair, and companies must not be distracted by fairness if they are to succeed (the same is true for investors). CYDY seems focused on keeping their heads down and generating the data that is needed to move forward, and contrary to what STAT news keeps insisting, the totality of available data supports the conclusion that CCR5 is an important therapeutic target in multiple indications. I can't guarantee that CYDY will succeed against the many headwinds that small biotech companies face, nor am I thrilled about the slow pace of progress and occasional setbacks, but I continue to hold my shares because I don't feel that the thesis has changed. An approval of some type (EUA, BLA, etc) still seems likely for CYDY in the near future.
I've been wanting to add my perspective as a long-time regulatory professional after seeing the statement from FDA yesterday, hearing doom and gloom summaries of the CC from various naysayers, and then listening to the CC myself. TL
R summary = I thought the call went very well given the circumstances, and things still seem to be on track. First and foremost I was impressed with the unified, conciliatory and friendly tone of CYDY management towards FDA, which must have been a challenging position to take after the events of yesterday. This means they are clearly focused on moving forward with US FDA, and that they are not willing to indulge in conspiracy theories of BP/FDA corruption and other distractions which (whether true or not) are just that - distractions. If Nader and CYDY management ever decide to start indulging such distractions and stop focusing on making forward progress, I will promptly sell all of my shares.
The tone and content of the FDA statement from yesterday was consistent with many I have read before in confidential correspondence with them. The only reason I can think that it was published on FDA's website is that they must have been facing overwhelming public advocacy for Leronlimab, and clearly some of it (probably a lot of it) was from people who are misinformed. Some of this can be fairly blamed on the hyperbole of CYDY executive management, which I've unfortunately found to be ubiquitous among small biotech C-suites; however, some blame must also go to FDA, who has made a number of high-profile blunders and questionable approvals throughout this pandemic. Regardless, over the years I have regularly had to reassure stakeholders that FDA is simply incredibly risk-averse, and their written correspondence should not be taken personally. It is unfortunate that their statement was made publicly available to shareholders at large, who have clearly over-reacted given that no new information was shared with us.
Finally, the clarity Nader provided on their move overseas makes perfect sense in the context of drug development: if you live in a country where there are no patients in your intended treatment population (i.e. severe COVID), you must go overseas to enroll patients. It had nothing to do with FDA asserting that there was no path forward for Leronlimab. This was a straightforward and sensible answer to my main question of what precipitated the move overseas, and whether it had to do with bad blood here in the US.
In sum: I'm not surprised by the FDA letter, although I feel its publication was unfair to CYDY shareholders. However, life is often unfair, and companies must not be distracted by fairness if they are to succeed (the same is true for investors). CYDY seems focused on keeping their heads down and generating the data that is needed to move forward, and contrary to what STAT news keeps insisting, the totality of available data supports the conclusion that CCR5 is an important therapeutic target in multiple indications. I can't guarantee that CYDY will succeed against the many headwinds that small biotech companies face, nor am I thrilled about the slow pace of progress and occasional setbacks, but I continue to hold my shares because I don't feel that the thesis has changed. An approval of some type (EUA, BLA, etc) still seems likely for CYDY in the near future.
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