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Posted On: 08/15/2022 9:19:38 PM
Post# of 148899
Solid post.
Corp Strategy:
1. Strengthening our pharmacovigilance program enabling us to remove the FDA clinical holds placed on our HIV and COVID-19 programs to allow us to conduct future clinical studies.
(This will be the first step to the HIV BLA being submitted fully. In fact, “As of March 2022, the FDA commenced its review of the CMC section.”)
(Basically stating that the BLA is already being reviewed. We were told that the FDA would review our BLA by sections and they have started.)
2. Advancing our NASH program to a Phase 2b or Phase 2b/3 trial for steatosis and liver fibrosis associated with NASH.
(Sounds like being 1 of 4 poster presentations got big pharma attention. As we know, many big pharmas stopped their Nash trials or recently failed and SK said they would interact with them per an older CC).
3. Exploring a study for patients with HIV and NASH.
(This one-two combo should not be overlooked. Slowly some bashers have said that HIV indication wouldn’t bring us money and that we would have to pay our partner, but what they missed was a study on HIV / Nash combo. Making us the only drug in the world to explore this; while having statistical significance in HIV phase 3, AND with the same drug, @ 350mg showing significantly reduced cT1 from baseline to week 14 versus placebo in NASH.)
4. Contining our Phase 2 program for metastatic triple-negative breast cancer with current standard of care, explore a Phase 2 colon cancer trial with current standard of care, and explore other solid tumor indications.
(G, SK said we would be an oncology company and that we would have multiple partnerships such as Humira, a drug worth up to $6K+).
5. Continuing our work to evaluate the feasibility and timelines for the HIV BLA resubmission and explore other cancer and immunologic indications for leronlimab, continue our work on developing a long-acting version of leronlimab, and pursue proof of concept studies for HIV cure using leronlimab and AAV vectors.
(The HIV cure and LAL (Long Acting Leronlimab will further seperate us from competition).
6. Reviewing our strategy for our COVID-19 program.
This one is interesting since:
“Brazil: Additionally, the Company paused two clinical trials in Brazil which commenced during fiscal 2022.”
Another tidbit pointed out:
Pg 45: “Despite the Company’s negative working capital position, vendor relations remain accommodative and we do not currently anticipate significant delays in our business initiatives schedule due to liquidity constraints." -Kolibri
A clinical project manager position was shortly posted after the 10K with 31 applications as of the moment I type this.
It could be one or all of the corporate strategies listed.
Shorts can say all they want, but who even uses game over anymore?
We are on continue
Corp Strategy:
1. Strengthening our pharmacovigilance program enabling us to remove the FDA clinical holds placed on our HIV and COVID-19 programs to allow us to conduct future clinical studies.
(This will be the first step to the HIV BLA being submitted fully. In fact, “As of March 2022, the FDA commenced its review of the CMC section.”)
(Basically stating that the BLA is already being reviewed. We were told that the FDA would review our BLA by sections and they have started.)
2. Advancing our NASH program to a Phase 2b or Phase 2b/3 trial for steatosis and liver fibrosis associated with NASH.
(Sounds like being 1 of 4 poster presentations got big pharma attention. As we know, many big pharmas stopped their Nash trials or recently failed and SK said they would interact with them per an older CC).
3. Exploring a study for patients with HIV and NASH.
(This one-two combo should not be overlooked. Slowly some bashers have said that HIV indication wouldn’t bring us money and that we would have to pay our partner, but what they missed was a study on HIV / Nash combo. Making us the only drug in the world to explore this; while having statistical significance in HIV phase 3, AND with the same drug, @ 350mg showing significantly reduced cT1 from baseline to week 14 versus placebo in NASH.)
4. Contining our Phase 2 program for metastatic triple-negative breast cancer with current standard of care, explore a Phase 2 colon cancer trial with current standard of care, and explore other solid tumor indications.
(G, SK said we would be an oncology company and that we would have multiple partnerships such as Humira, a drug worth up to $6K+).
5. Continuing our work to evaluate the feasibility and timelines for the HIV BLA resubmission and explore other cancer and immunologic indications for leronlimab, continue our work on developing a long-acting version of leronlimab, and pursue proof of concept studies for HIV cure using leronlimab and AAV vectors.
(The HIV cure and LAL (Long Acting Leronlimab will further seperate us from competition).
6. Reviewing our strategy for our COVID-19 program.
This one is interesting since:
“Brazil: Additionally, the Company paused two clinical trials in Brazil which commenced during fiscal 2022.”
Another tidbit pointed out:
Pg 45: “Despite the Company’s negative working capital position, vendor relations remain accommodative and we do not currently anticipate significant delays in our business initiatives schedule due to liquidity constraints." -Kolibri
A clinical project manager position was shortly posted after the 10K with 31 applications as of the moment I type this.
It could be one or all of the corporate strategies listed.
Shorts can say all they want, but who even uses game over anymore?
We are on continue
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