Replies to post #1998 on Biomoda Inc. (fka BMODQ)

[The Rainmaker]

So let’s take a look at all of the steps and look how Biomoda performed in the process.

Step 1: Determining if it is a Medical Device

This may sound ridiculous, but this is actually a very important step in the device approval process. Because medical devices can include anything from special toilet paper to bed pans and medical pumps. Since we know that the Cypath will be used for testing cancer this step is a no-brainer.

Step 2: Determining if it is Low Risk

Obviously Cypath will not be a low risk Medical Device. Why? Because patients are going to make life or death decisions based on their tests’ outcome.

Step 3: Is this similar to a previously approved Medical Device

Alright, this is one of my favorite steps, because what we have here is basically an endorsement from the FDA that says that either the device has a clearly defined competitor that makes a similar product or they don’t. If the FDA decides that the device is not similar to a previously approved medical device then that simply means that this device is one of a kind and there is nothing else out there like it. However, this does not mean that the device will become the most used or the most relied upon device in that indication. So it is a double-edged sword. Remember a lot of doctors like to use what they know and new devices don’t exactly fall at the top of the list. But, since Cypath is relatively cheap and harmless and falls in the “unique device” category I don’t see a reason a doctor wouldn’t have it ordered. So the market share could be significant.

Step 4: Does the study of the device pose a significant risk?

Since we are dealing with cancer test here the answer is automatically yes. Additionally, a patient’s sputum (basically it is mucus and phlem from a cough) has to be administered TCPP for Biomoda to run the test, but I would say the FDA’s significant risk factor here is a misdiagnosed patient. So that means that the company will have to go through with the Investigation Device Exemption (IDE) process. Usually this is where the company will determine if they think their device is a Class I, II, or III device as defined by the FDA. The class indications are broken down as so:

Class I: Low risk, general controls sufficient over the counter products, adhesive bandages, hospital beds

Class II: Performance standards & general control physician controlled distribution, oxygen masks, blood-pressure cuffs, powered wheelchairs

Class III: Require pre-market approval. These are devices that: “support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential unreasonable risk of illness or injury”

Since Biomoda’s device basically determines if a patient has cancer or not, the device is classified as a Class III device and therefore will have to go through a little more stringent reporting standards.

Step 5: IDE (Investigational Device Exemption) Application:

Ok this is the portion where a lot of investors get confused, because before a company submits an IDE they usually meet with the FDA in what is called a Pre-IDE meeting. So let’s go over what a Pre-IDE meeting is and why it is important. A Pre-IDE meeting simply provides a forum for gaining feedback from FDA on well-defined questions. Basically a firm submits an agenda and five to seven questions to the FDA 30 to 60 days in advance. The company then discusses with the FDA various aspects of the regulatory pathway, the proper approach to refine and/or define clinical data and statistical analyses, and to answer critical questions related to clinical study design. So basically any company worth their salt will have sought a pre-IDE meeting with the FDA. Luckily Biomoda has done just that. (additional information on pre-IDE meetings can be found at the FDA website here).

After the Pre-IDE meeting, the company usually submits the IDE. The IDE is simply the equivalent of an Investigational New Drug Application, except that it is for devices. In a nutshell the company is requesting from the FDA permission to test the device on humans in clinical trials. The company submits an IDE to the FDA and the IRB (Intuitional Review Board), which then make a decision as to whether the company is allowed to go ahead with their clinical trials. This is why the pre-IDE meeting is of the upmost importance, because a company can basically ask the FDA whether or not the proposed clinical trials and investigational path that they are taking would be appropriate or good enough to garner the approval of an IDE. Again, Biomoda delivered on this part and got approval on March 5, 2009 from the IRB and FDA to begin testing in human subjects. As of October 2009, they are in Phase I and II clinical trials testing their test on several patients and in fact have garned the support of several state and federal agencies in the process (the official clinical trial listing can be found here).

Step 6: The PMA (Premarket Approval) Process:

Ok, now here is what I call the betting point. The premarket approval process is almost identical to the New Drug Approval (NDA) process. In case you aren’t familiar with the NDA process I’ll run through the PMA process thoroughly (the FDA’s PMA webpage is here, although it is rather dry reading).

The Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Approval of the PMA is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use. An approved PMA also grants a private license with permission to market the device. The PMA owner, however, can also authorize use of its data by another company. Like drugs, the FDA has set user fee for the approval process and it is known as the Medical Device User Fee Act. The MDUFA basically charges a fee to the company for the costs of the approval process, and the regulations also provide 180 days for the FDA to review the PMA and make a determination. But in reality, the review time is normally longer. Before approving or denying a PMA, the appropriate FDA advisory committee usually reviews the PMA at a public meeting to provide the FDA with the committee’s recommendation on whether FDA should approve the submission.

Since Biomoda is cancer test and contains molecular entities it is more than likely that The Center for Biologic, Evaluation, Research (CBER) will be the advisory committee that they meet with when they submit their application.