Optifinancial Newsletter - Knowledge is power - Brad Mitchell
This is not financial advice nor recommendations. This is purely our own thoughts and opinions regarding the matter discussed below for entertainment purposes. This is not advice and is never intended to be.
Disclosure: We own BIOR securities/shares at the time of publication. This could affect my biases in my analysis.
Biora | $0.69
The preliminary study results are in: You can eat and still take the DDS pill safely and effectively know that it will work!
This past week investors received a press release showing that Biora has completed a Fasting vs Fed State study. They suggested that the pill shows capability to be used during meal time. This is promising and adds substantial value to their technology. From my research and background, I have mentioned this as being a large bonus for the company if they were able to have success in this study.
The PM-611 study highlights that they are the first company to ever create a pill that has the technology to deploy drug site specific locations and allow users to eat normally. This is a very important step towards their commercial value. If you look at the doctor/patient compliance, you must look at the end user. If the end user does not like the product due to constraints, the product may not be used as often due to ease of integration into the patient’s life. From my own experience (photo below), I use a Dexcom product to help control my diabetes type 1. It differs from the other competition due to the ease of use and user friendly-ness.
Also a little side note: The applicator above was created by Novo engineering, this is the same design firm that also created Biora’s DDS product line. I’d say that this is a very strong hint that Biora’s product (when deployed commercially) will supersede quality and producibility.
From Biora’s recent study, they highlighted that they actually had 46 pills in total. No adverse events and no errors were found. Impressive. The quantity of pills and quality of the pills they used shines through. They are getting better at scaling which will be important in the future. 12 patients were involved in this study. Each patient took 4 pills, (Excluding a patient who took 2) Of those 46 pills, 43 were captured. And Only 39 were able to get data retrieved from. I was asked by a few on: why Biora may not have been able to collect all 46 & why from the 43, they only had data from 39 of the 43 pills. The study required patients to take 4 pills, and assuming that they went home at night and had to come back, I’d say that some pills were captured and from the digestive process, may have been damaged after the pill released its saline compound. The digestive process takes 2-5 days. This is a much longer and more variable time than you’d expect. It takes food roughly 6-8 hours to get to the large intestine (colon) and it can dwell for 36 hours. Because of this variability, you might see it being pretty hard to capture all pills from their study. Personal Experience: I have actually been in a clinical diabetic research study before. When I was first diagnosed, the research facility actually had a clinical phase 1 drug that they wanted to see if it could essentially counteract my diabetes by using an immunosuppressant on the t-cells. The amount of information I had to collect and write down was extraneous. Some of my data was missing as it was very difficult to keep up with the requirements they had. I’d expect some human error in retrieval and collecting the data from the DDS pills. These pills were not designed to be reopened and get data extracted. I’d assume that they did not use the radio function to send software to the app or device as they are probably wanting to keep the cost of the study low.
This PM-611 study adds real value to their company. Further information will be submitted and released as they finish their analysis.
We should expect a 3rd study “PM-602” with their DDS to be performed in the clinical setting for patients with Active Ulcerative Colitis. They will be using the Pfizer’s drug Xeljanez (Tofacitinib) in a liquid form to test it’s effectiveness in the patients. We should expect the results in the 3rd Quarter this year. Be READY for this release.
Current Price: $0.69
The company at this stage will look very different from today. They will have established a dominance in the oral delivery market with a wide moat of research and patent protection. The partnerships that they are working on today will start to bear fruit during this time.
If Biora is not bought out, we should see them bloom like Dexcom. They have a medical device that will serve the needs of patients and give doctors the feedback that they will always want to have. It will be hard for doctors who prescribe drugs to not want to use a patient compliance mechanism such as Biora’s DDS or OBDS. Another note to make is that insurance will want to have this data in hand as well. Biora will most likely have many other drug candidates in their pipelines with funding from partners to validate their drugs.
Disclosure: We own BIOR securities/shares at the time of publication
All stocks talked about we have invested in, and do not intend to give advice nor recommend acting upon the information.
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Until next week,
and the Optifinancial Team
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