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Posted On: 07/15/2020 1:20:02 PM
Post# of 148908
Re: generactor #43088
During the call, it was discussed that the company was expecting to have the question about how the rest of the mono patients at 700mg faired in the trial, they just assumed it would be during the review process.
While it would have been hard to provide this data in April/May when the trial data was being submitted, it is much easier now since the last patient finished their 1 year treatment in June.
NP has consistently said that the FDA is being helpful and adapting processes to facilitate their review and potential approval. NP is proactively praising the FDA, if he wasn’t happy with them he could simply say nothing.
By talking about the FDA positively I believe he is addressing all the FDA conspiracy theorists that appear here and elsewhere.
I choose to believe the viewpoint of the CEO and CRO lead on the combo trial who have all the info rather that the host of FDA haters here most of who have probably never interacted with the FDA much less worked In the industry.
To further emphasize my point, when the company has been unhappy within the FDA, they say it - remember when Jay L complained about how long it took to get the first COVID trial approved because they did not understand how Leronlimab would work. In addition they continue to question the effectiveness of Remdesivir which we all know the FDA approved for EUA.
There does not seem to be concern from the company on the HIV front and I think we all should trust the opinion of our leaders who have all the info on this but i realize that some people will probably never change their opinion because the FDA is a good scapegoat and most have never worked in a pharma company so this is an area they are not very knowledgeable.
IMO
While it would have been hard to provide this data in April/May when the trial data was being submitted, it is much easier now since the last patient finished their 1 year treatment in June.
NP has consistently said that the FDA is being helpful and adapting processes to facilitate their review and potential approval. NP is proactively praising the FDA, if he wasn’t happy with them he could simply say nothing.
By talking about the FDA positively I believe he is addressing all the FDA conspiracy theorists that appear here and elsewhere.
I choose to believe the viewpoint of the CEO and CRO lead on the combo trial who have all the info rather that the host of FDA haters here most of who have probably never interacted with the FDA much less worked In the industry.
To further emphasize my point, when the company has been unhappy within the FDA, they say it - remember when Jay L complained about how long it took to get the first COVID trial approved because they did not understand how Leronlimab would work. In addition they continue to question the effectiveness of Remdesivir which we all know the FDA approved for EUA.
There does not seem to be concern from the company on the HIV front and I think we all should trust the opinion of our leaders who have all the info on this but i realize that some people will probably never change their opinion because the FDA is a good scapegoat and most have never worked in a pharma company so this is an area they are not very knowledgeable.
IMO
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