Is there a history of the FDA delaying a BTD respo
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Posted On: 01/13/2020 11:04:52 AM
Re: ClosetInvestor #14914
Quote:
Is there a history of the FDA delaying a BTD response to request more data? And can CYDY submit data from the 2 additional patients to the FDA to support the already filed BTD packet?
I would say yes there is and yes they can.....see this post for reference:
https://investorshangout.com/post/view?id=5641082
Additionally, I believe the FDA views unmet medical needs for cancer (particularly deadly cancers such as TNBC) much differently than combo HIV resistant patients. This is only my opinion, but personally I view these differently also simply from a compassionate perspective.....do you feel sorry for someone who engages in risky behavior and something bad happens to them......then they get treatment that works, but then they don't follow the protocol and something else bad happens to them......or someone who was out of the blue diagnosed and passed of cancer in a short timeframe?
I'm not trying to get political or be insensitive, this is just my view of one reason the FDA has delayed combo HIV and why I think it will be different with cancers. Secondly, they have a proven exceptional safety record and the alternative treatment options are not in the same zip code as leronlimab IMO.
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Please do your own due diligence. All my posts and comments are not to be considered investment advice.
