Some snippets from yesterday's conference, these are NP words mostly from my memory so I reality can be slightly different. Have tried to reproduce as accurate as possible.
Combo:
Everything was ready for submission FDA came back with 700 mg due to success in Mono and wanted to have that data. BLA application middle or end of December.
Monotherapy: Have answered to FDA questions of higher response rate (2016), resistance. Lack of response for some patients, another (I cannot remember). Hopefully have label extension after combo is approved.
Pivotal trial ready to go. FDA needs to give guidance on inclusion criteria and protocol design. Hopefully meeting with FDA soon.
Waiting “permission” from FDA to summit either 525mg or700 mg.
mTNBC: Stunning results. Two more patients “as soon as possible”, if in 2-3 weeks we see CTC reduction and tumor shrink we will request BTD designation maybe THIS year.
“Make no mistake we showed these results to our regulatory team, to the scientist that were in charge of this program and with our Dr. B Patterson who is behind guiding us in the right direction and they said: the results are stunning” (one patient only). tumor shrank to quickly that the oncologist said it had “never seen a tumor to shrank so quickly”.
NASH: Can provide earlier results (economic) and provide a tremendous amount of funding. Will seek licensing agreement. Already talking with companies. Results in days not weeks.
Animal study results in days.
PrEP: Dr. Sacha reported “very fantastic” results on prevention (40000 new infected patients). Countries “need our drug”. Trying to get the news to the right people in the white house. Trying to make it available.
Might heard about CROI paper application today.
GvHD: Results are “spectacular: 100% of mice survived after being injected with human bone marrow. They should all had died, Lero “saved them”. Maybe this month patient injected. In kind of backburner, it takes 100 says per patient to get results.
Prostate: cannot talk at this time.
Cancer in general: Latest animal data have convinced them that perhaps there is no need for more animal studies and instead go for basket trial submit p2 for all the cancers that has metastasize with CCR5 microphages around the tumor.
Impressive mouse data started p1/p2;
General: Cast of patents is very long. 57 Patents in 60 countries. Very expensive to maintain.
Path forward: Borrow money with IP as collateral.
Stock price: company “under attack” with stock price at a level “unheard of”, maybe broke a world record.
No R/S !!. Up-listing based only on organic increase on price. He voted against that in board.
Open minded about a BO but for the right amount of money, "investors have gone through an unbelievable amount of time patience and we will not drop the ball by selling the company, for any indication, for less than it is worth."
Combo:
Everything was ready for submission FDA came back with 700 mg due to success in Mono and wanted to have that data. BLA application middle or end of December.
Monotherapy: Have answered to FDA questions of higher response rate (2016), resistance. Lack of response for some patients, another (I cannot remember). Hopefully have label extension after combo is approved.
Pivotal trial ready to go. FDA needs to give guidance on inclusion criteria and protocol design. Hopefully meeting with FDA soon.
Waiting “permission” from FDA to summit either 525mg or700 mg.
mTNBC: Stunning results. Two more patients “as soon as possible”, if in 2-3 weeks we see CTC reduction and tumor shrink we will request BTD designation maybe THIS year.
“Make no mistake we showed these results to our regulatory team, to the scientist that were in charge of this program and with our Dr. B Patterson who is behind guiding us in the right direction and they said: the results are stunning” (one patient only). tumor shrank to quickly that the oncologist said it had “never seen a tumor to shrank so quickly”.
NASH: Can provide earlier results (economic) and provide a tremendous amount of funding. Will seek licensing agreement. Already talking with companies. Results in days not weeks.
Animal study results in days.
PrEP: Dr. Sacha reported “very fantastic” results on prevention (40000 new infected patients). Countries “need our drug”. Trying to get the news to the right people in the white house. Trying to make it available.
Might heard about CROI paper application today.
GvHD: Results are “spectacular: 100% of mice survived after being injected with human bone marrow. They should all had died, Lero “saved them”. Maybe this month patient injected. In kind of backburner, it takes 100 says per patient to get results.
Prostate: cannot talk at this time.
Cancer in general: Latest animal data have convinced them that perhaps there is no need for more animal studies and instead go for basket trial submit p2 for all the cancers that has metastasize with CCR5 microphages around the tumor.
Impressive mouse data started p1/p2;
General: Cast of patents is very long. 57 Patents in 60 countries. Very expensive to maintain.
Path forward: Borrow money with IP as collateral.
Stock price: company “under attack” with stock price at a level “unheard of”, maybe broke a world record.
No R/S !!. Up-listing based only on organic increase on price. He voted against that in board.
Open minded about a BO but for the right amount of money, "investors have gone through an unbelievable amount of time patience and we will not drop the ball by selling the company, for any indication, for less than it is worth."
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