Innovation Pharmaceuticals Inc (IPIX)

[kfcyahoo]

"B has not been cleared by the FDA. Meaning patients outside of trials are not permitted to use."

I don't think so.

https://www.fda.gov/ForPatients/Other/ExpandedAccess/ucm20041768.htm#what-does-fda-consider

Excerpts from the link below

What does the FDA Consider When Reviewing my Request?
When a treating physician requests expanded access to an investigational drug , the FDA must determine if the patient or patients to be treated have a serious or immediately life-threatening disease or condition. The Code of Federal Regulations (21 CFR Part 312.300) details how expanded access can be granted and what steps the FDA needs to follow.

Doctors Reviewing Expanded Access Requrest
It is important to have a discussion with your physician or healthcare provider to see if your current disease or condition can be defined as either:

A serious disease/condition: a disease or condition associated with morbidity that has substantial impact on day-to-day functioning. Short-lived and self-limiting morbidity will usually not be sufficient, but the morbidity need not be irreversible, provided it is persistent or recurrent. Whether a disease or condition is serious is a matter of clinical judgment, based on its impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one; or

Immediately life threatening: a disease or condition is a stage of disease in which there is reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.

The FDA must also determine that:

There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.

The patient cannot obtain the drug under another IND or protocol.

The potential patient benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease or condition to be treated.

Providing the investigational drug will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the expanded access use or otherwise compromise the potential development of the expanded access use.

If I Meet the Criteria, Will I Qualify for Expanded Access/Compassionate Use to a Drug?
Not necessarily. Even if you meet the criteria, there may still be obstacles.

Your physician may not be able to obtain expanded access for you because of your medical history or the risks associated with taking an investigational drug. Your physician must determine that the probable risk from the drug is not greater than the probable risk from the disease.

Your physician may not be willing to manage the use of an investigational drug.

The company that makes the drug is not required to offer it outside their clinical trials, and they may not be willing or able to do so.

The company may not have enough of the drug available for all patients requesting expanded access. Some companies establish a lottery system to determine which patients will have treatment access. Others make the decision on a case-by-case basis.

Investigational drugs are expensive to make. The drug company may request authorization from FDA to charge you the direct costs of making the drug available, such as manufacturing and shipping, and indirect costs, such as reporting and IRB approval, or it may elect to cover the cost. Remember that most insurance companies will not pay for access to an investigational drug and that there may be additional cost for administering them and then for monitoring of the IND by your hospital or healthcare provider. These costs do not require FDA authorization. It is important that you and your physician consider the cost of the investigational drug and the medical services associated with its use that are not covered by third-party payers such as insurance or Medicare.