It is my assumption (and it is only an assumption)
Post# of 155516
(Total Views: 651)
Posted On: 09/06/2020 2:13:42 PM
Re: craigakess #54400
It is my assumption (and it is only an assumption) that the meeting with the FDA on Tuesday is limited to the Combo HIV filing, and the FDA's very generous offer (/sarcasm) to inflict further delays by kicking the can down the road yet again for at least another month with a Multidisciplinary Review that is not necessary.
The FDA's repeated and blatant attempts at preventing this indication from being approved rises to the level of being criminal. And it is my hope that the FDA team responsible for this obstructionist behavior is fired and blacklisted if/when the UK MHRA quickly approves both Combo and Mono HIV indications.
I assume further that the FDA team responsible for processing the Combo HIV filing is completely different from the team analyzing the CD10 results. As such, I'd be very surprised to learn that the COVID filing is even raised in the Tuesday HIV meeting. Of course, I could be wrong.
Taken as a whole, the US response to this virus has been abysmal. And a large part of this failure seems to be rooted in a lack of coordination between various agencies. The US always fails with large scale emergencies -- with Katrina being the poster child for this inefficiency.
I wonder if CytoDyn's discussion with the UK MHRA relating to COVID is even on the radar of the FDA team responsible for CD10 approval. And similarly, if CytoDyn's discussion with the UK MHRA relating to Combo and Mono HIV is even on the radar of the FDA team responsible for Combo HIV approval.
Alternatively, the FDA and MHRA may very well be back-channeling discussions regarding these filings due to a MHRA UK - FDA Confidentiality Commitment that someone recently posted. Let's hope not, because this agreement would represent an avenue for the FDA to negatively influence the UK MHRA on both of these indications. I am confident that Big Pharma would like nothing more than to use the FDA as a conduit for squashing CytoDyn approvals in ex-US countries. This agreement allows that to happen.
MHRA UK - FDA Confidentiality Commitment
Source Link: https://www.fda.gov/international-programs/co...commitment
Excerpt:
The FDA's repeated and blatant attempts at preventing this indication from being approved rises to the level of being criminal. And it is my hope that the FDA team responsible for this obstructionist behavior is fired and blacklisted if/when the UK MHRA quickly approves both Combo and Mono HIV indications.
I assume further that the FDA team responsible for processing the Combo HIV filing is completely different from the team analyzing the CD10 results. As such, I'd be very surprised to learn that the COVID filing is even raised in the Tuesday HIV meeting. Of course, I could be wrong.
Taken as a whole, the US response to this virus has been abysmal. And a large part of this failure seems to be rooted in a lack of coordination between various agencies. The US always fails with large scale emergencies -- with Katrina being the poster child for this inefficiency.
I wonder if CytoDyn's discussion with the UK MHRA relating to COVID is even on the radar of the FDA team responsible for CD10 approval. And similarly, if CytoDyn's discussion with the UK MHRA relating to Combo and Mono HIV is even on the radar of the FDA team responsible for Combo HIV approval.
Alternatively, the FDA and MHRA may very well be back-channeling discussions regarding these filings due to a MHRA UK - FDA Confidentiality Commitment that someone recently posted. Let's hope not, because this agreement would represent an avenue for the FDA to negatively influence the UK MHRA on both of these indications. I am confident that Big Pharma would like nothing more than to use the FDA as a conduit for squashing CytoDyn approvals in ex-US countries. This agreement allows that to happen.
MHRA UK - FDA Confidentiality Commitment
Source Link: https://www.fda.gov/international-programs/co...commitment
Excerpt:
Quote:
Both regulatory authorities consider that from time to time circumstances will arise in which sight and/or knowledge of information held by one authority will assist the other in conducting its regulatory functions in relation to medical devices or of ensuring the safety, quality, and efficacy of medicinal products for human use under clinical investigation, authorised for marketing, or under review for marketing authorisation in both the US and the UK.
Therefore, the MHRA is pleased to co-operate with the FDA to facilitate the sharing of otherwise non-public documents and information for these purposes and by this document set out a framework understanding of the information which they may share with each other and the basis upon which they may share it. This co-operation and framework understanding shall not create any kind of binding legal obligation on the part of the MHRA or the FDA.
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