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Tetra Bio Pharma Inc (OTCMKTS:TBPMF) Speaks Out About Its HCC011



Tetra Bio Pharma Inc (OTCMKTS:TBPMF) is quite pleased to get to the trial period of its product known as HCC011. This is a product developed purposefully for patients struggling with a condition called hepatocellular carcinoma.

Effects of HCC011 on liver cancer and other conditions

The other name commonly used to refer to this condition is primary liver cancer. It has been affecting a lot of people around the globe. Experts point to it as the cause of most of the primary malignant liver tumors adults have been struggling with. They specify that about 80% of the reported cases start with this condition.

This company says that HCC011 will give cancer patients wide-ranging health benefits to enhance their lives. Asides from that, this group will also benefit from the anti-tumor effects that come with consuming this product.

The product HCC011 is expected to move through a Phase 2 study. This is in the hope of helping patients struggling with a condition treated using Sorafenib. Patients are also going to administered dosages by inhalation, and this will be done three times a day. Sorafenib is going to be combined with this drug in this experiment, and researchers seek to make reports regarding unacceptable toxicity levels.

Response evaluation will help researchers determine the disease control rate effectively. They will also be seeking to monitor aspects such as the time to progression and the overall survival.

The company also intends to serve patients with the product’s anti-emetic effects. This will help improve the quality of their life according to the business guru.

Filing NDA

The other move the company wants to make is the filing of the product’s NDA. It intends to accomplish this through the 505(b)(2) pathway. The FDA has some very coherent pathways through which drugs can gain approval. The 505(b)(2) new drug application (NDA) happens to be one of them.

This company says that the 505(b)(2) provisions favor a select group of manufacturers in a major way. Provided they have some particular forms of drugs, they would get approval from the body more easily. That is, without having to go through the hassle of those with the standard 505(b) (1) NDA.

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