A lot of positives to take from the CC. I like tha
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Posted On: 03/22/2021 6:31:56 PM
A lot of positives to take from the CC. I like that we have indeed filed for EUA’s or equivalent across the board with the majority of countries we expressed in our PR last week. Working still on the rest and added one more country to the mix in Hungary. It means we have a chance yet albeit it small chance to achieve a EUA on the CD-12 trial. That’s encouraging!
The pre-BTD meeting on Cancer with the FDA is super exciting. Just letting them know we have something special happening is exciting and so it’s not a shock to them when we actually file for BTD.
The receptor occupancy of Leronlimab compared to Merck’s drug Marivoc (spelling?) is quite substantial. Marivoc has only 40-50% occupancy compared to 100% in Leronlimab. Wow... sounds like a future slam dunk when comparing for Long Haulers or cancer or whatever avenue Merck chooses to venture with their CCR5 antagonist. Leronlimab will out perform in all facets. Important to our investment.
BLA’s for HIV in both Duel and mono filed as soon as May in Canada and maybe June or July for everyone else. Should have RO complete by then with new vendor. Looks promising for HIV revenue at least in the UK this year with 74 day approval process. The first HIV approval will surely be the UK due to speedy process.
Love the change in trial design with the CD-16 and now a CD-17 is brilliant to attack the over 65 age group with a quick IV dose and then two more dose injections. Could prove to be a great thing and reminds me of a quote Dr Jay Lalazari. He said he begged the FDA for up to 4 doses in the CD-12 trial. Depending on how severe the patient was.
We didn’t get the big news I know I was hoping to hear. EUA is not out of the question though. That EUA news can still happen and it’s not ruled out. Possible EUA still in play is a great thing. Many other good things too were brought foreword and a great overall CC. We have a bright future in my opinion and Oncology is the brightest star for us. Everything else is a beautiful thing. Revenue is on the cusp it would seem but this year we will have a few avenues of revenue when it’s all said and done.
The pre-BTD meeting on Cancer with the FDA is super exciting. Just letting them know we have something special happening is exciting and so it’s not a shock to them when we actually file for BTD.
The receptor occupancy of Leronlimab compared to Merck’s drug Marivoc (spelling?) is quite substantial. Marivoc has only 40-50% occupancy compared to 100% in Leronlimab. Wow... sounds like a future slam dunk when comparing for Long Haulers or cancer or whatever avenue Merck chooses to venture with their CCR5 antagonist. Leronlimab will out perform in all facets. Important to our investment.
BLA’s for HIV in both Duel and mono filed as soon as May in Canada and maybe June or July for everyone else. Should have RO complete by then with new vendor. Looks promising for HIV revenue at least in the UK this year with 74 day approval process. The first HIV approval will surely be the UK due to speedy process.
Love the change in trial design with the CD-16 and now a CD-17 is brilliant to attack the over 65 age group with a quick IV dose and then two more dose injections. Could prove to be a great thing and reminds me of a quote Dr Jay Lalazari. He said he begged the FDA for up to 4 doses in the CD-12 trial. Depending on how severe the patient was.
We didn’t get the big news I know I was hoping to hear. EUA is not out of the question though. That EUA news can still happen and it’s not ruled out. Possible EUA still in play is a great thing. Many other good things too were brought foreword and a great overall CC. We have a bright future in my opinion and Oncology is the brightest star for us. Everything else is a beautiful thing. Revenue is on the cusp it would seem but this year we will have a few avenues of revenue when it’s all said and done.
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