The Philippines FDA has just installed a faster path to approval. The Executive Order just allows them to use a “Me too” clause using other countries approvals for a faster approval for a overall faster mechanism for the Philippines. I think a lot of countries will do that. The process and review hasn’t really changed all that much with the exception to a over 50% of a phase 3 trial clause.
If you meet the 3 criteria’s they laid out and file for your first ever EUA approval of a drug and using only the Philippines as the first to approve world wide. They just state that they will be able to review and approve a EUA within a months time. It’s an improvement over the standard 6 month review but really gives leeway to make decisions quickly. A day, a week, a month... Will this benefit CytoDyn is the question?
What I believe it does do, is no different than what the authority of our very own FDA has. Our FDA approved EUA’s on a couple of drugs with little to no proven benefit at the time of approval. The Executive Order they did, just gave them the same authority to approve a EUA with a certain criteria to meet. All though it looks like we check all the boxes of the 3 criteria requirements.
Maybe this is an equal playing field for CytoDyn to file for both EUA’s in the USA and the Philippines on the same day? Making it a competition to speed up the process for an EUA? We know and have made public that we only have 1.2 million doses or ability to treat only 600,000 patients. Will this motivate one or the other to get in line to approve and make a deal sooner than later. That is another question.
The difference going forward is the interim results of more than 50% trial results qualify for an review in the Philippines as soon as our 75% interim is complete or almost complete. Another question is. Do we have to unblind to send our results to the Philippines? Or will our CD-12 trial be complete and it doesn’t matter and unblinding isn’t even a factor?
I would say that the results will be available for review in the Philippines without a 42 day wait for the 75% interim review to file for the EUA. That the door opened by the Executive Order was just that. An advantage to take earlier results with over 50% completion of a phase 3 trial.
So if we are either completing our results for our 75% interim look and total completion of the trial is attained. If we have complete results of a say 60% of patients in our trial complete with the 28 or 42 day end point. Should be able to show 60% with 42 day end points with no trouble. We can use that clause and could submit even earlier because we are using that over 50% of trial completion results that the Philippines is allowing. We also will have an additional 2 months or very close to two months of safety data that they also require following results of the trial.
Therefore the Philippines will have a time saving ability to approve a little sooner as long our completion of the trial is complete before the 42 days after the 75% interim look so unblinding isn’t even in question.
Hurry up and finish the trial is what we need. Then unblinding isn’t a factor and a earlier EUA can happen in the Philippines. That’s what I see as a benefit it what that press release is telling us. If our trial completes 42 days after our 75% interim look we are going to the Philippines for our first EUA approval. They allowed us that advantage of time by an over 50% phase 3 clause with no time restrictions.
If you meet the 3 criteria’s they laid out and file for your first ever EUA approval of a drug and using only the Philippines as the first to approve world wide. They just state that they will be able to review and approve a EUA within a months time. It’s an improvement over the standard 6 month review but really gives leeway to make decisions quickly. A day, a week, a month... Will this benefit CytoDyn is the question?
What I believe it does do, is no different than what the authority of our very own FDA has. Our FDA approved EUA’s on a couple of drugs with little to no proven benefit at the time of approval. The Executive Order they did, just gave them the same authority to approve a EUA with a certain criteria to meet. All though it looks like we check all the boxes of the 3 criteria requirements.
Maybe this is an equal playing field for CytoDyn to file for both EUA’s in the USA and the Philippines on the same day? Making it a competition to speed up the process for an EUA? We know and have made public that we only have 1.2 million doses or ability to treat only 600,000 patients. Will this motivate one or the other to get in line to approve and make a deal sooner than later. That is another question.
The difference going forward is the interim results of more than 50% trial results qualify for an review in the Philippines as soon as our 75% interim is complete or almost complete. Another question is. Do we have to unblind to send our results to the Philippines? Or will our CD-12 trial be complete and it doesn’t matter and unblinding isn’t even a factor?
I would say that the results will be available for review in the Philippines without a 42 day wait for the 75% interim review to file for the EUA. That the door opened by the Executive Order was just that. An advantage to take earlier results with over 50% completion of a phase 3 trial.
So if we are either completing our results for our 75% interim look and total completion of the trial is attained. If we have complete results of a say 60% of patients in our trial complete with the 28 or 42 day end point. Should be able to show 60% with 42 day end points with no trouble. We can use that clause and could submit even earlier because we are using that over 50% of trial completion results that the Philippines is allowing. We also will have an additional 2 months or very close to two months of safety data that they also require following results of the trial.
Therefore the Philippines will have a time saving ability to approve a little sooner as long our completion of the trial is complete before the 42 days after the 75% interim look so unblinding isn’t even in question.
Hurry up and finish the trial is what we need. Then unblinding isn’t a factor and a earlier EUA can happen in the Philippines. That’s what I see as a benefit it what that press release is telling us. If our trial completes 42 days after our 75% interim look we are going to the Philippines for our first EUA approval. They allowed us that advantage of time by an over 50% phase 3 clause with no time restrictions.
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