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Posted On: 07/13/2023 11:01:17 PM
Post# of 148891
Interesting hypothesis from someone on Reddit. It's long, but pretty well thought out in my opinion. I needed some reason for optimism, and this filled the bill at least a little. Don't visit Reddit much, so no idea what this person's track record is. Seems like they know a lot about the landscape of biotechs.
Patented Landscape and Clinical Hold
There are a ton of things I want to clarify and there is not enough space. I am going to focus on the two things today and other thoughts in other posts:
On 7/11/23 CYDY filed 424B3, which is an amendment form that the SEC requires companies to file if they wish to change, amend, or add info to their registered prospectus without altering the prospectus in original form. The original S-1 form was filed on 6-21-23.
Patents from 424B3: "We currently, absent patent term extension, that patent protection relating to the leronliamb antibody itself started to expire in 2023, the leronliamb concentrated protein formulation will start to expire in 2031, certain methods of using LL for treatment of HIV1 will start to expire on or before 2035. and for cancer indications if granted will start to expire in 2040, for treatment of COVID-19 start to expire in 2040, treatment of NASH if granted will start to expire in 2043.
Patents and FDA exclusivity:
In the U.S., a patent claiming a new biological product, its method of use or its method of manufacture may be eligible for a limited patent term extension under the Hatch Waxman Act, which permits a patent extension of up to five years for patent term lost during the product development and FDA regulatory review. "
Let's ask questions about the patent protection relating to the leronliamb antibody itself started to expire in 2023, the leronliamb concentrated protein formulation will start to expire in 2031. I am not a patent expert or a lawyer. But the Hatch Waxman Act certainly applies to the patent expiring in 2023. No doubt about it; Amarex screw ups have delayed regulatory review. I would like the conference call to address whether they are making efforts to utilize the Hatch Waxman act to extend the patented to 2028. Next question: Scott Kelly stated the key patent for LL is the concentrated protein formulation (expire in 2031). Does this mean that the original patent expiring 2023 hopefully extended to 2028 relating to the antibody itself is not really important? Does it mean that the antibody itself is not really effective without the concentrated protein? If someone on these boards knows, please explain and also tells us how you know. Thank you
Patents/Marketing exclusivity: from 424B3 Reference Product Exclusivity for Biological Products: "With approval of a BLA, a biological product (LL) is licensed for marketing by the FDA, and the product may be entitled to certain types of market and data exclusivity barring FDA from approving competing products for certain periods of time. In the U.S. a reference biological product is granted 12 years of exclusivity from the time of first licensure of the product and the first approved interchangeable biological product will be granted an exclusivity period of up to one year after it is first commercially marketed. The FDA will not accept an application for a biosimilar or interchangeable product until after four years after the date of first licensure of the reference product.
As I see it, so far, just talking about the patents, you can create an argument that once the clinical hold is lifted, CYDY should have a new BLA for HIV at the ready to submit. It is entirely possible that there has been some back and forth with the FDA regarding the clinical hold and the BLA. As PharmaJunkee has pointed out a couple of times at least 90% of everything we know that was submitted is the same info that would be submitted on an HIV BLA. Why is it important to submit the BLA. The obvious answer is first and foremost; it adds value too CYDY. In negotiations whether they be partnerships or buyouts a submitted and accepted BLA adds value to our side of the equation.
CLINICAL HOLD:
There has been some questions by posters on different boards whether or not it is necessary for CYDY to even finish their efforts regarding the lifting of Clinical Hold. Based on my above comments I truly believe CYDY is doing everything they can to supply the FDA with all of the requested documents.
In form 424B3: "Recent efforts by the company have been focused on activities that will allow us to resolve this partial clinical hold." This tells me they are close and committed to the effort of lifting of the hold. I do not have a date in mind. I thought it would have happened by now. If you read posts by spazzy, she is stating the lift of the hold will be in 49 days as of 7/13/23. Let's say she is right: Thursday August 31 is 49 days away. I still feel like it will happen sooner but I can wait a lot longer than 49 days.
I do not anticipate the CC to announce anything substantial. Substantial material news is announced within 72 hours of the company receiving it. It is possible to receive news within the 72 hours and the scheduled CC, but that is coincidence. In order of what material news could happen is 1) Amarex settlement 2) Lifting of the clinical Hold. 3) Formal announcements of Key officers CMO, and CEO 4) Partnerships 5) if we don't see a formal announcement of CEO in 6-8 months it leads me to think buyout is close at hand. If we get a CEO announcement with in 3-4 months we have partnerships happening probably from the company this person may have worked with in the past. I think the two weeks out was to give Cyrus more time to build his strength and get healthier and get caught up on things; so he can deliver updates on the CC.
CYDY is getting awarded money from the Arbitration. And it clearly stated in the press release and the MSA agreement that the lawyers for CYDY will get paid by Amarex. It will not come out of the damages awarded to CYDY. That money is significant but IMO it does not stop CYDY from pursuing Partnership opportunities and or buyout. It just gives us more time and value just like submitting and acceptance of the BLA. MORE VALUE for CYDY!!
https://www.reddit.com/r/LeronLimab_Times/com...ical_hold/
Patented Landscape and Clinical Hold
There are a ton of things I want to clarify and there is not enough space. I am going to focus on the two things today and other thoughts in other posts:
On 7/11/23 CYDY filed 424B3, which is an amendment form that the SEC requires companies to file if they wish to change, amend, or add info to their registered prospectus without altering the prospectus in original form. The original S-1 form was filed on 6-21-23.
Patents from 424B3: "We currently, absent patent term extension, that patent protection relating to the leronliamb antibody itself started to expire in 2023, the leronliamb concentrated protein formulation will start to expire in 2031, certain methods of using LL for treatment of HIV1 will start to expire on or before 2035. and for cancer indications if granted will start to expire in 2040, for treatment of COVID-19 start to expire in 2040, treatment of NASH if granted will start to expire in 2043.
Patents and FDA exclusivity:
In the U.S., a patent claiming a new biological product, its method of use or its method of manufacture may be eligible for a limited patent term extension under the Hatch Waxman Act, which permits a patent extension of up to five years for patent term lost during the product development and FDA regulatory review. "
Let's ask questions about the patent protection relating to the leronliamb antibody itself started to expire in 2023, the leronliamb concentrated protein formulation will start to expire in 2031. I am not a patent expert or a lawyer. But the Hatch Waxman Act certainly applies to the patent expiring in 2023. No doubt about it; Amarex screw ups have delayed regulatory review. I would like the conference call to address whether they are making efforts to utilize the Hatch Waxman act to extend the patented to 2028. Next question: Scott Kelly stated the key patent for LL is the concentrated protein formulation (expire in 2031). Does this mean that the original patent expiring 2023 hopefully extended to 2028 relating to the antibody itself is not really important? Does it mean that the antibody itself is not really effective without the concentrated protein? If someone on these boards knows, please explain and also tells us how you know. Thank you
Patents/Marketing exclusivity: from 424B3 Reference Product Exclusivity for Biological Products: "With approval of a BLA, a biological product (LL) is licensed for marketing by the FDA, and the product may be entitled to certain types of market and data exclusivity barring FDA from approving competing products for certain periods of time. In the U.S. a reference biological product is granted 12 years of exclusivity from the time of first licensure of the product and the first approved interchangeable biological product will be granted an exclusivity period of up to one year after it is first commercially marketed. The FDA will not accept an application for a biosimilar or interchangeable product until after four years after the date of first licensure of the reference product.
As I see it, so far, just talking about the patents, you can create an argument that once the clinical hold is lifted, CYDY should have a new BLA for HIV at the ready to submit. It is entirely possible that there has been some back and forth with the FDA regarding the clinical hold and the BLA. As PharmaJunkee has pointed out a couple of times at least 90% of everything we know that was submitted is the same info that would be submitted on an HIV BLA. Why is it important to submit the BLA. The obvious answer is first and foremost; it adds value too CYDY. In negotiations whether they be partnerships or buyouts a submitted and accepted BLA adds value to our side of the equation.
CLINICAL HOLD:
There has been some questions by posters on different boards whether or not it is necessary for CYDY to even finish their efforts regarding the lifting of Clinical Hold. Based on my above comments I truly believe CYDY is doing everything they can to supply the FDA with all of the requested documents.
In form 424B3: "Recent efforts by the company have been focused on activities that will allow us to resolve this partial clinical hold." This tells me they are close and committed to the effort of lifting of the hold. I do not have a date in mind. I thought it would have happened by now. If you read posts by spazzy, she is stating the lift of the hold will be in 49 days as of 7/13/23. Let's say she is right: Thursday August 31 is 49 days away. I still feel like it will happen sooner but I can wait a lot longer than 49 days.
I do not anticipate the CC to announce anything substantial. Substantial material news is announced within 72 hours of the company receiving it. It is possible to receive news within the 72 hours and the scheduled CC, but that is coincidence. In order of what material news could happen is 1) Amarex settlement 2) Lifting of the clinical Hold. 3) Formal announcements of Key officers CMO, and CEO 4) Partnerships 5) if we don't see a formal announcement of CEO in 6-8 months it leads me to think buyout is close at hand. If we get a CEO announcement with in 3-4 months we have partnerships happening probably from the company this person may have worked with in the past. I think the two weeks out was to give Cyrus more time to build his strength and get healthier and get caught up on things; so he can deliver updates on the CC.
CYDY is getting awarded money from the Arbitration. And it clearly stated in the press release and the MSA agreement that the lawyers for CYDY will get paid by Amarex. It will not come out of the damages awarded to CYDY. That money is significant but IMO it does not stop CYDY from pursuing Partnership opportunities and or buyout. It just gives us more time and value just like submitting and acceptance of the BLA. MORE VALUE for CYDY!!
https://www.reddit.com/r/LeronLimab_Times/com...ical_hold/
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