A tour de Force
Post# of 148187
(Total Views: 861)
Posted On: 03/05/2020 6:23:24 PM
“Tour de force” meeting !!.
My "memory and notes recollection of the meeting".. I added some comments and emphasis sometimes and I am sure I am forgetting a lot. But … what a meeting full of information.
We are cooking with gas here
.
______________________________________________________
BLA clinical has been finalized!!! (remember we have rolling application and this is the one that takes more time to study by FDA).
Manufacturing part will take 2-3 weeks more to be ready.
There will not be any dilutive financing. So we can rest easy with this one.
Financing is coming. Several possibilities (4 investors under evaluation). Most likely will be benign debt.
Coronavirus: one hour ago IND and protocol have been completed. Expected to file FDA tomorrow. Announcement on Monday with all details. Quest clinical in San Francisco ready to inject first patient New York Presbiterian Brooklyn Methodist want to enroll patients Stefano Rusconi in Italy wan to enroll patients also.
Going full blast with Nash
Up-Listing a priority, however the cash in hand requirements ($100M NSE, $90M NASDAQ) are such that is better to wait until financing or deals are made.
Will probably present in conference American Association of cancer research
Commercial name: Virologics
Question about GILD: “GILD: I am hoping we don’t get an offer until we get a BTD designation. If somebody offers something and shareholders approve I am up for it.”
Dr. Patterson in Coronavirus: Of the 20 companies listed in article most are working on Vaccine or anti-viral. Only one (us) is ready with a good safety profile.
IND and protocol for MS in a couple of weeks.
March 29 meeting: Oncologist Pathologists, radiologists, open discussion and great opportunity to share ideas and come up with strategies.
BTD for MTNBC applied on January 10th updated data on Feb 6th. According to FDA guidelines 60 Days Will be up on 6 days or so unless they choose to reset the date.
New BTD we have IND, Lazerai have received. Have 2 patients with different cancers and another one we could file based in mechanism of action. Lab doctor called several times and say that he had never seen such results so definitely there are responders.
TFDA for Cancer, HIV and Coronavirus” Already signed letter of intent an NDA 30 days started already. AMAREX was the venue. They shared data with their branch in Taiwan so it will be expedited for BTD for cancer and for HIV. They want to see some paints from that region.
CFDA document already transferred. They already transmitted them to CFDA, so is in progress.
Longen: 9 days from today Letter of Intent will lapse. Working hard on final term sheet. Will inform what happens and if it happens.
Licensing with another very solid company with financial background (Taiwan) will be announcing something shorty. Both companies want to buy 24K plus 600K vials of commercial grade Leronlimab for Coronavirus and Oncology. Might get to the point that we are short of vials.
Update in patients:
7 Injected Yesterday 3/4/2020
8 Will be Injected Friday 3/6/2020
9 Passed screening date TBD
10 Passed screening date TBD
11 Will be Phase1/2b in Houston site
12 Will be Phase 1/2b in Houston site
My "memory and notes recollection of the meeting".. I added some comments and emphasis sometimes and I am sure I am forgetting a lot. But … what a meeting full of information.
We are cooking with gas here
. ______________________________________________________
BLA clinical has been finalized!!! (remember we have rolling application and this is the one that takes more time to study by FDA).
Manufacturing part will take 2-3 weeks more to be ready.
There will not be any dilutive financing. So we can rest easy with this one.
Financing is coming. Several possibilities (4 investors under evaluation). Most likely will be benign debt.
Coronavirus: one hour ago IND and protocol have been completed. Expected to file FDA tomorrow. Announcement on Monday with all details. Quest clinical in San Francisco ready to inject first patient New York Presbiterian Brooklyn Methodist want to enroll patients Stefano Rusconi in Italy wan to enroll patients also.
Going full blast with Nash
Up-Listing a priority, however the cash in hand requirements ($100M NSE, $90M NASDAQ) are such that is better to wait until financing or deals are made.
Will probably present in conference American Association of cancer research
Commercial name: Virologics
Question about GILD: “GILD: I am hoping we don’t get an offer until we get a BTD designation. If somebody offers something and shareholders approve I am up for it.”
Dr. Patterson in Coronavirus: Of the 20 companies listed in article most are working on Vaccine or anti-viral. Only one (us) is ready with a good safety profile.
IND and protocol for MS in a couple of weeks.
March 29 meeting: Oncologist Pathologists, radiologists, open discussion and great opportunity to share ideas and come up with strategies.
BTD for MTNBC applied on January 10th updated data on Feb 6th. According to FDA guidelines 60 Days Will be up on 6 days or so unless they choose to reset the date.
New BTD we have IND, Lazerai have received. Have 2 patients with different cancers and another one we could file based in mechanism of action. Lab doctor called several times and say that he had never seen such results so definitely there are responders.
TFDA for Cancer, HIV and Coronavirus” Already signed letter of intent an NDA 30 days started already. AMAREX was the venue. They shared data with their branch in Taiwan so it will be expedited for BTD for cancer and for HIV. They want to see some paints from that region.
CFDA document already transferred. They already transmitted them to CFDA, so is in progress.
Longen: 9 days from today Letter of Intent will lapse. Working hard on final term sheet. Will inform what happens and if it happens.
Licensing with another very solid company with financial background (Taiwan) will be announcing something shorty. Both companies want to buy 24K plus 600K vials of commercial grade Leronlimab for Coronavirus and Oncology. Might get to the point that we are short of vials.
Update in patients:
7 Injected Yesterday 3/4/2020
8 Will be Injected Friday 3/6/2020
9 Passed screening date TBD
10 Passed screening date TBD
11 Will be Phase1/2b in Houston site
12 Will be Phase 1/2b in Houston site
(15)
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