Posted by: BooDog
In reply to: KarinCA who wrote msg# 223254 Date:4/4/2018 12:23:27 PM
Post #223257 of 223258
Gladly. And I'm sure over the years you've seen it happen plenty of times on other pre phase III bio's. Patients can request to stay on medication or apply through the treating physician to apply to start taking a medication through the Expanded Access Program.
Quick excerpts from two companies...
Physicians and patients should consider all possible benefits and risks when seeking expanded access to an investigational medicine—so a patient should seek the advice of his or her treating physician.
Physicians who would like to receive more information regarding the availability of a particular investigational medicine through expanded access on behalf of their patients should contact ######Pharma at ######.com. ######Pharma will acknowledge receipt of all requests within 2 business days of receiving them. Different countries have various regulatory procedures required for compassionate use of an investigational medicine. In all cases, compassionate use must be allowed by local law and local regulatory approval for the proposed use is required.
Decisions about providing drug will be made solely by ###### in accordance with its policies and procedures. ######’s acceptance and processing of this application does not guarantee that access to investigational product will be provided.
Whether it's for brilacidin or for prurisol, IPIX appears to be getting onboard with this by advertising the program on their website.
https://www.ipharminc.com/expanded-access-and...onate-use/
By this statement it may be more for kevetrin and/or brilacidin...
As part of drug development, the FDA allows for potential Expanded Access / Compassionate Use of an Investigational New Drug before any regulatory approval might be achieved. This opportunity applies only to patients with serious or life-threatening conditions who are unable to participate in a clinical trial and have exhausted alternative treatment avenues.
But it's possible for prurisol as well imo.
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Okay, so I left out the names of the other companies because the post would likely get deleted. But if anyone's interested here are the two companies. I'm more familiar with Corbus.
http://www.ctibiopharma.com/clinical-trials/p...onate-use/
https://www.corbuspharma.com/physicians/acces...-therapies
In reply to: KarinCA who wrote msg# 223254 Date:4/4/2018 12:23:27 PM
Post #223257 of 223258
Gladly. And I'm sure over the years you've seen it happen plenty of times on other pre phase III bio's. Patients can request to stay on medication or apply through the treating physician to apply to start taking a medication through the Expanded Access Program.
Quick excerpts from two companies...
Physicians and patients should consider all possible benefits and risks when seeking expanded access to an investigational medicine—so a patient should seek the advice of his or her treating physician.
Physicians who would like to receive more information regarding the availability of a particular investigational medicine through expanded access on behalf of their patients should contact ######Pharma at ######.com. ######Pharma will acknowledge receipt of all requests within 2 business days of receiving them. Different countries have various regulatory procedures required for compassionate use of an investigational medicine. In all cases, compassionate use must be allowed by local law and local regulatory approval for the proposed use is required.
Decisions about providing drug will be made solely by ###### in accordance with its policies and procedures. ######’s acceptance and processing of this application does not guarantee that access to investigational product will be provided.
Whether it's for brilacidin or for prurisol, IPIX appears to be getting onboard with this by advertising the program on their website.
https://www.ipharminc.com/expanded-access-and...onate-use/
By this statement it may be more for kevetrin and/or brilacidin...
As part of drug development, the FDA allows for potential Expanded Access / Compassionate Use of an Investigational New Drug before any regulatory approval might be achieved. This opportunity applies only to patients with serious or life-threatening conditions who are unable to participate in a clinical trial and have exhausted alternative treatment avenues.
But it's possible for prurisol as well imo.
Quote:Message in reply to:
You've mentioned the following several times now and I haven't a clue how it would come into play at this point in time for the company.
Quote:
Compassionate use comes into play.
Please explain how you see this coming into play. I just don't see it and am curious as to your thinking.
==============================
Okay, so I left out the names of the other companies because the post would likely get deleted. But if anyone's interested here are the two companies. I'm more familiar with Corbus.
http://www.ctibiopharma.com/clinical-trials/p...onate-use/
https://www.corbuspharma.com/physicians/acces...-therapies
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