$Outlook Therapeutics (OTLK.US)$ From OUTLOOKS Website! If y...
$Outlook Therapeutics(OTLK.US$ From OUTLOOKS Website! If you read? Pay attention to last Paragraph! ![]()
So our mission is to enhance the standard of care in retina by achieving the first honest to goodness FDA approval for Bevacizumab in ophthalmology.
Our Bevacizumab is actually going to be, have a level of differentiation relative to the Bevacizumab the doctors have had access to and been quite successful within an off label format over the last 15 or 20 years.
And it's really by virtue of the fact that for us to earn the right to get an FDA approval in ophthalmology and the right to inject this in a patient's eyes, there are a vast number of standards that are required in ophthalmology that are not requirements for a parenteral that was designed to go into a drip IV and treat oncology. So the rules, regulations, and validations that we have for ensuring there's the right amount of drug particulate, in every single vial or every single syringe is very strict. We need to validate that. We also need to have an utter lack of particulates. In our solution, the requirements for us for particulates that are 10 microns or larger. In each one of our containers, we can only have 50. You're allowed to have up to 6000 for a parenteral that gets delivered into a drip IV for oncology.
We also have specifications around pH levels, endotoxin levels. Our packaging has to be approved. We have to show stability and shelf life; something that can't really get a good read on for something that is repackaged from a compound or, and then, comes out later, not really knowing how much time you have to use that product. We'll probably launch with about two years of dating and, soon after that, up to three years of dating. So all these requirements that FDA has in ophthalmology are key. We met them for the biologic that was used in our clinical trial. And the data that came out of there were amazing. We had almost 42% of our patients gained 3 lines of vision or 15 letters. Over 56% gain 10 letters or 2 lines, and almost 70% of the patients gained 5 letters or an entire line. On top of that, at every single time point at the 12 post op checkups for our patients 80% of them gained or maintain vision at every single time point, and that the majority of the time points, it was more than 85% of the patients gained or maintain vision.
So we've got to PDUFA date coming up on August 29. Wish us luck! We're hoping for for an approval on that date, and should we achieve that approval on August 29, that would put us in a position to begin shipping in the fourth quarter of this year.
Our Bevacizumab is actually going to be, have a level of differentiation relative to the Bevacizumab the doctors have had access to and been quite successful within an off label format over the last 15 or 20 years.
And it's really by virtue of the fact that for us to earn the right to get an FDA approval in ophthalmology and the right to inject this in a patient's eyes, there are a vast number of standards that are required in ophthalmology that are not requirements for a parenteral that was designed to go into a drip IV and treat oncology. So the rules, regulations, and validations that we have for ensuring there's the right amount of drug particulate, in every single vial or every single syringe is very strict. We need to validate that. We also need to have an utter lack of particulates. In our solution, the requirements for us for particulates that are 10 microns or larger. In each one of our containers, we can only have 50. You're allowed to have up to 6000 for a parenteral that gets delivered into a drip IV for oncology.
We also have specifications around pH levels, endotoxin levels. Our packaging has to be approved. We have to show stability and shelf life; something that can't really get a good read on for something that is repackaged from a compound or, and then, comes out later, not really knowing how much time you have to use that product. We'll probably launch with about two years of dating and, soon after that, up to three years of dating. So all these requirements that FDA has in ophthalmology are key. We met them for the biologic that was used in our clinical trial. And the data that came out of there were amazing. We had almost 42% of our patients gained 3 lines of vision or 15 letters. Over 56% gain 10 letters or 2 lines, and almost 70% of the patients gained 5 letters or an entire line. On top of that, at every single time point at the 12 post op checkups for our patients 80% of them gained or maintain vision at every single time point, and that the majority of the time points, it was more than 85% of the patients gained or maintain vision.
So we've got to PDUFA date coming up on August 29. Wish us luck! We're hoping for for an approval on that date, and should we achieve that approval on August 29, that would put us in a position to begin shipping in the fourth quarter of this year.
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