Some notes from CC: FDA response for pre-IND
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Posted On: 08/26/2020 10:20:29 AM
Some notes from CC:
FDA response for pre-IND briefing package for vaccine: Rich Purcell says "very happy with response" from FDA wich basically gave protocol design approval with no additional toxicology necessary.
Moscata introduced Worldwide Digitech's Dr. Levine who says he's very happy and priviledged to be part of the organization.
Sanjay Kumar running Arizona operation - Arizona is the third largest medicare recipient state in country ... three primary care clinics and one of the largest endicronology centers in the country... close to 50k medicare centers... four clinics and then will spread out to Florida and California... will then go to Texas, Oklahoma and other states... will be one of the top four or five most patient monitoring operations in the country.
Moscatto: Last week signed an LLI for a guaranteed $400M minimum with China for vaccine, if successful. $5M up front.
Moscatto: Partnership with Malaysia... manufacturing facilities to produce vaccine for that country. Contract signing up to $150M deal... $2.5M upon contract signing to further develop vaccine and they pay for all costs in Malaysia. If approved, licensing fee of $17.5M plus royalties of $3-4 dollars per dose administered.
Moscatto: Canadian review with over 60 submissions from companies... been working with them for over a month. They want to move our vaccine forward and in early stages of discussion but we are confident of a successful outcome.
Moscatto: ALTuCell - big goal is to get that aquisition done.
Gary of ALTuCell - in process of execution of our own study in
Human study in Italy been pushed back because of transplants ... have all approvals with government to execute human trial, first in world to reverse Type-I diabetes. Five year study with encapsulation technology.
Moscatto: Partnered with Texas based diagnostics company for infectious disease as well as cancer.
Tony Balisi - Awarded by VA a BPA contract in late March to allow to conduct business in all 465 hospitals associated with VA as well as over 1000 clinics. Been shut down due to Covid-19 and just now beginning to reopen to elective surgeries. Only opening at 25% compacity to accomodate patients.... not been able to fully take advantage of contract at this point but been recruiting and getting ready to handle. Want to launch into the 1000 clinics and podiatry offices . ... been diligent recruiting, hiring, training and relationships are in place with VA facilities.
Jason - partnering with Aima Bio - Emegene Covid Diagnostic test... wide variety of different specimens can be tested on. FDA approved home based sample kits. Their lab is unique as they're using state-of-the-art top of the line facility and euqipment providing improved, more accurate, better and faster results... in Texax will be able to perform 1.4M tests a month.... have applied for FDA EUA... expecting approvals in coming days to weeks.
Rick - Regeneris Update - ultrativ colitis - clinical trial starting in Australia. Also in Israel.
Moscatto: Vaccine work getting involved with a few other countires.
Recently heard from BARDA - we were difficient in some areas we knew about. 3M agiment with no safety data or testing preclinical data so got that from NIH and a reference letter for that agiment prior to our application submission... have that to use and to use all their NIH safety data. Plan to get our testing results back and adding along with protocol and FDA response as well as cross-reference letter fron NIH to RESUMBIT and we will be totally compliant.
FDA response for pre-IND briefing package for vaccine: Rich Purcell says "very happy with response" from FDA wich basically gave protocol design approval with no additional toxicology necessary.
Moscata introduced Worldwide Digitech's Dr. Levine who says he's very happy and priviledged to be part of the organization.
Sanjay Kumar running Arizona operation - Arizona is the third largest medicare recipient state in country ... three primary care clinics and one of the largest endicronology centers in the country... close to 50k medicare centers... four clinics and then will spread out to Florida and California... will then go to Texas, Oklahoma and other states... will be one of the top four or five most patient monitoring operations in the country.
Moscatto: Last week signed an LLI for a guaranteed $400M minimum with China for vaccine, if successful. $5M up front.
Moscatto: Partnership with Malaysia... manufacturing facilities to produce vaccine for that country. Contract signing up to $150M deal... $2.5M upon contract signing to further develop vaccine and they pay for all costs in Malaysia. If approved, licensing fee of $17.5M plus royalties of $3-4 dollars per dose administered.
Moscatto: Canadian review with over 60 submissions from companies... been working with them for over a month. They want to move our vaccine forward and in early stages of discussion but we are confident of a successful outcome.
Moscatto: ALTuCell - big goal is to get that aquisition done.
Gary of ALTuCell - in process of execution of our own study in
Human study in Italy been pushed back because of transplants ... have all approvals with government to execute human trial, first in world to reverse Type-I diabetes. Five year study with encapsulation technology.
Moscatto: Partnered with Texas based diagnostics company for infectious disease as well as cancer.
Tony Balisi - Awarded by VA a BPA contract in late March to allow to conduct business in all 465 hospitals associated with VA as well as over 1000 clinics. Been shut down due to Covid-19 and just now beginning to reopen to elective surgeries. Only opening at 25% compacity to accomodate patients.... not been able to fully take advantage of contract at this point but been recruiting and getting ready to handle. Want to launch into the 1000 clinics and podiatry offices . ... been diligent recruiting, hiring, training and relationships are in place with VA facilities.
Jason - partnering with Aima Bio - Emegene Covid Diagnostic test... wide variety of different specimens can be tested on. FDA approved home based sample kits. Their lab is unique as they're using state-of-the-art top of the line facility and euqipment providing improved, more accurate, better and faster results... in Texax will be able to perform 1.4M tests a month.... have applied for FDA EUA... expecting approvals in coming days to weeks.
Rick - Regeneris Update - ultrativ colitis - clinical trial starting in Australia. Also in Israel.
Moscatto: Vaccine work getting involved with a few other countires.
Recently heard from BARDA - we were difficient in some areas we knew about. 3M agiment with no safety data or testing preclinical data so got that from NIH and a reference letter for that agiment prior to our application submission... have that to use and to use all their NIH safety data. Plan to get our testing results back and adding along with protocol and FDA response as well as cross-reference letter fron NIH to RESUMBIT and we will be totally compliant.
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