Pertinent information in case anyone needs it - th
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Posted On: 12/24/2020 9:27:07 AM
Pertinent information in case anyone needs it - thanks to C-20 from the other board:
"I can probably add a little to this discussion since my wife's doc was just able to get an EIND for LL from the FDA. The whole process takes longer than you might expect, especially considering they're using the term 'emergency'.
1- you need to find a doctor who will even consider using a non approved drug.
2- that doc will then want to do some research on LL, at a time when these doctors are already badly overworked. This research may or may not include a conversation with the FDA.
3- the doc will need to get a 'letter of authorization' from Cytodyn to the FDA. Template available on FDA website. This tells the FDA that Cytodyn is on board, willing and able to provide the drug if they approve.
4- the doc then makes a formal request to FDA. In our case it was still 2 days from request to approval. This may speed up as they issue more but FDA will still want to access patients condition before approval, so there will be some time involved I believe.
5- if you get approval now they have to get the LL to you. Could be another day or 2 depending on a few factors.
In our case my wife stabilized her first couple days on the vent and then her lung function started improving. Her improvement made it easier to deal with these 'delays' in getting her the LL.
To answer your vent question, the conversation my doc had with FDA inferred that the shorter amount of time the patient is on a vent the more likely it will help the patient. No brainer. But the doc mentioned 2-3 weeks as a vent time frame that may indicate less chance of success. Hope this helps"
GLTA
"I can probably add a little to this discussion since my wife's doc was just able to get an EIND for LL from the FDA. The whole process takes longer than you might expect, especially considering they're using the term 'emergency'.
1- you need to find a doctor who will even consider using a non approved drug.
2- that doc will then want to do some research on LL, at a time when these doctors are already badly overworked. This research may or may not include a conversation with the FDA.
3- the doc will need to get a 'letter of authorization' from Cytodyn to the FDA. Template available on FDA website. This tells the FDA that Cytodyn is on board, willing and able to provide the drug if they approve.
4- the doc then makes a formal request to FDA. In our case it was still 2 days from request to approval. This may speed up as they issue more but FDA will still want to access patients condition before approval, so there will be some time involved I believe.
5- if you get approval now they have to get the LL to you. Could be another day or 2 depending on a few factors.
In our case my wife stabilized her first couple days on the vent and then her lung function started improving. Her improvement made it easier to deal with these 'delays' in getting her the LL.
To answer your vent question, the conversation my doc had with FDA inferred that the shorter amount of time the patient is on a vent the more likely it will help the patient. No brainer. But the doc mentioned 2-3 weeks as a vent time frame that may indicate less chance of success. Hope this helps"
GLTA
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