I agree. The list is tough but fair...
I still see through a tiny window of opportunity in our CD-12 extension. The FDA wouldn’t of granted us an extension unless they hoped they would get us to an EUA. So please explain the reasoning that they would give us an extension for any other reason? It’s like they said... well 62 patients and iffy results don’t add up to enough confidence for us to take it to my boss and then their boss to seek an EUA. If we knocked it out of the park with 62 people... ok... let’s argue about it.
I find it reassuring that the FDA gave us this opportunity to improve our results and achieve efficacy and trial strength for our CD-15 trial. That’s huge in my book. They could of done so much worse. Tell to start over. Raise our patient count to a 1000. Yet here we stand complaining about anything and everything from the past. Not that there isn’t everyone’s right to complain.
My thoughts are did we hit 70 people and what day was that so we can count down the 28 days and then estimate the ability to gather the information on those people. If it happened a week or two ago that we hit 55 people then have we hit 70 already this past week? When do we start the clock on the fastest way for us to achieve an EUA? Is Nader going to update us on the 70 people they deemed necessary to achieve EUA? Is Nader playing this card close to his chest for nobody to see? Or will he say we have hit that number now and in 28 days we will have those great results we talked about in the 16.7% mortality. Sometimes we just have to read between the lines. The lines can be blurry.
The quickest approval for EUA in the USA is this journey I just laid out for us. It’s not over on the CD-12 trial just yet. We have not been turned down. We have been told to show us better results in an extension and we will consider you. That is another chance to set the age gap evenly and to somehow average the rather higher than normal placebo mortality that nobody expected. If our 70 patients average results to more normal expectations. Then we are in great shape in my opinion.
This is our big chance and some of you just can’t see it. Let hope the extension is our first of many successes.
It is for the benefit of all of us to take a step back and see the big picture of what is transpiring. There has to be a reason we haven’t broken down the door on a new protocol after having one submitted and approved then we just tread water for what? It’s like throwing pasta at the wall to see if it will stick. We are doing the ground work for more trials it seems but do we really want to do more? How close are we now to knowing the results of the 70 patients? 5 weeks? 6 weeks? Less? More? Only time will tell. It is our fastest path in the USA for an EUA. Let’s hope for the best and not dwell on the past. We have things to look forward to. Looking back isn’t the brightest picture for t he longs. I know because when I invested the HIV BLA was suppose to be files in a month in Sept. 2019. That didn’t happen. It took until June 2020. Then you know the rest of the story.
This was no way directed at you Bored Lawyer... I agreed then went much further than I thought I would. It always seems like I have much to say. Sorry...
I still see through a tiny window of opportunity in our CD-12 extension. The FDA wouldn’t of granted us an extension unless they hoped they would get us to an EUA. So please explain the reasoning that they would give us an extension for any other reason? It’s like they said... well 62 patients and iffy results don’t add up to enough confidence for us to take it to my boss and then their boss to seek an EUA. If we knocked it out of the park with 62 people... ok... let’s argue about it.
I find it reassuring that the FDA gave us this opportunity to improve our results and achieve efficacy and trial strength for our CD-15 trial. That’s huge in my book. They could of done so much worse. Tell to start over. Raise our patient count to a 1000. Yet here we stand complaining about anything and everything from the past. Not that there isn’t everyone’s right to complain.
My thoughts are did we hit 70 people and what day was that so we can count down the 28 days and then estimate the ability to gather the information on those people. If it happened a week or two ago that we hit 55 people then have we hit 70 already this past week? When do we start the clock on the fastest way for us to achieve an EUA? Is Nader going to update us on the 70 people they deemed necessary to achieve EUA? Is Nader playing this card close to his chest for nobody to see? Or will he say we have hit that number now and in 28 days we will have those great results we talked about in the 16.7% mortality. Sometimes we just have to read between the lines. The lines can be blurry.
The quickest approval for EUA in the USA is this journey I just laid out for us. It’s not over on the CD-12 trial just yet. We have not been turned down. We have been told to show us better results in an extension and we will consider you. That is another chance to set the age gap evenly and to somehow average the rather higher than normal placebo mortality that nobody expected. If our 70 patients average results to more normal expectations. Then we are in great shape in my opinion.
This is our big chance and some of you just can’t see it. Let hope the extension is our first of many successes.
It is for the benefit of all of us to take a step back and see the big picture of what is transpiring. There has to be a reason we haven’t broken down the door on a new protocol after having one submitted and approved then we just tread water for what? It’s like throwing pasta at the wall to see if it will stick. We are doing the ground work for more trials it seems but do we really want to do more? How close are we now to knowing the results of the 70 patients? 5 weeks? 6 weeks? Less? More? Only time will tell. It is our fastest path in the USA for an EUA. Let’s hope for the best and not dwell on the past. We have things to look forward to. Looking back isn’t the brightest picture for t he longs. I know because when I invested the HIV BLA was suppose to be files in a month in Sept. 2019. That didn’t happen. It took until June 2020. Then you know the rest of the story.
This was no way directed at you Bored Lawyer... I agreed then went much further than I thought I would. It always seems like I have much to say. Sorry...
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