I can’t talk about the DSMC, but I have met with FDA policy makers a couple of times. My biggest takeaway was that their egos and arrogance know no bounds. They are a group that believes their authority over drug policy and approvals anoint them as having few peers on medical issues. They stare across the table with the attitude that their interlocutors are damn lucky to be able to meet with the FDA . So we don’t know how the dosage variance was presented by our lowly West Coast startup biopharma, But I can imagine an attitude of how dare you question our decisions. I am sure that when Merck comes to the meeting they bring a prestigious staff who have probably met with the FDA frequently.
On top of this, the FDA like many federal government agencies put new or changed regulations to the public for a public comment period. I would suggest that Merck has a group that watches and comments on the changed regulations to make sure they are favorable. (Merck being an example).
So I don’t support the dark conspiracies but would suggest a conspiracy of arrogance and of entrenched bureaucratics.
On a bit off topic, I must say that I am now less surprised by the vehemence of the FDA hit piece on our CD12 results. Seeing the total shambles of the Amarex submission on HIV BLA, the FDA must have been pissed off at the campaign for an EUA for Leronlimab last winter especially when they had rendered their verdict and we didn’t really hit end points except on a subset.
All IMHO
On top of this, the FDA like many federal government agencies put new or changed regulations to the public for a public comment period. I would suggest that Merck has a group that watches and comments on the changed regulations to make sure they are favorable. (Merck being an example).
So I don’t support the dark conspiracies but would suggest a conspiracy of arrogance and of entrenched bureaucratics.
On a bit off topic, I must say that I am now less surprised by the vehemence of the FDA hit piece on our CD12 results. Seeing the total shambles of the Amarex submission on HIV BLA, the FDA must have been pissed off at the campaign for an EUA for Leronlimab last winter especially when they had rendered their verdict and we didn’t really hit end points except on a subset.
All IMHO
17
