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THAT “attorney” WROTE ALL THAT, BUT NEVER READ....
THE ACTUAL COMPLAINT???! MAKES ZERO SENSE!!
** TWO TRIAL SITES RUN BY UNQUALIFIED PEOPLE**
And Javitt claims trial wasn’t “botched” or “tainted”
In his own words he says all Regional Hospitals could have been thrown out due to issues but furthers that
Specifically site 13&14 HAD UNLICENSED PEOPLE RUNNING HIS TRIAL!!!!
Based on the blinded analysis, we immediately sent a demand letter for investigation to site 14, in coordination with the Criminal Investigation Division of FDA, whom we notified of the 100% mortality. The investigation revealed that the licensed, trained investigators who signed the 1572 were not present to render care as per our clinical trial agreement – in one case apparently because of the effects of the pandemic and in the other because of a military deployment. The site brought in a non GCP-trained unqualified investigator without notifying us. That physician decided to exercise ad hoc “triage” in order to clear ICU beds. He therefore, over the objections of the onsite study coordinator, summoned the palliative care team and convinced the families of six subjects to terminate ICU care and ventilatory support with the expected fatal consequences. The investigation into site 14’s behavior is ongoing and FDA has involved other branches of law enforcement.
THE EMAIL BELOW WAS DATED JUNE 5th, 2021!!! DAYS AFTER SUBMISSION OF SECOND EUA!! ALL THIS WAS KNOWN, NOT COMMUNICATED TO US/PUBLIC, INSTEAD WE WERE TOLD
TO EXPECT EUA!!!!
** TWO TRIAL SITES RUN BY UNQUALIFIED PEOPLE**
And Javitt claims trial wasn’t “botched” or “tainted”
In his own words he says all Regional Hospitals could have been thrown out due to issues but furthers that
Specifically site 13&14 HAD UNLICENSED PEOPLE RUNNING HIS TRIAL!!!!
Based on the blinded analysis, we immediately sent a demand letter for investigation to site 14, in coordination with the Criminal Investigation Division of FDA, whom we notified of the 100% mortality. The investigation revealed that the licensed, trained investigators who signed the 1572 were not present to render care as per our clinical trial agreement – in one case apparently because of the effects of the pandemic and in the other because of a military deployment. The site brought in a non GCP-trained unqualified investigator without notifying us. That physician decided to exercise ad hoc “triage” in order to clear ICU beds. He therefore, over the objections of the onsite study coordinator, summoned the palliative care team and convinced the families of six subjects to terminate ICU care and ventilatory support with the expected fatal consequences. The investigation into site 14’s behavior is ongoing and FDA has involved other branches of law enforcement.
THE EMAIL BELOW WAS DATED JUNE 5th, 2021!!! DAYS AFTER SUBMISSION OF SECOND EUA!! ALL THIS WAS KNOWN, NOT COMMUNICATED TO US/PUBLIC, INSTEAD WE WERE TOLD
TO EXPECT EUA!!!!
https://iapps.courts.state.ny.us/nyscef/ViewDocument?docIndex=AX5pqPZYdEoE0SG7jcTw7A==&TSPD_101_R0=08533cd43fab20001faaa963620707b5d2a35a22829226644d99d3fc2743f76a94729171ea2b9c950862cb51bb14300019f46c96877780a68ab14d8fb7e60425e449964fbc5e74e74273b95bff546163a3dc5a4788529cc7c27121fc082802db
I DONT THINK THE PLACEMENT $ CAN BE USED FOR LEGAL COSTS
*** WOW READ NEW COURT DOCS, RIGHT AGAIN!***
*** WOW READ NEW COURT DOCS, RIGHT AGAIN!***
** I WAS RIGHT ALL ALONG... APOLOGIES ACCEPTED **
IF EUA WAS CLOSE WOULDNT THEY WAIT TO DILUTE
**** PROVEN RIGHT YET AGAIN.. APOLOGIES ACCEPTED ****
**NOT COMPETENT, AN EX US ATTORNEY?? Lol, Ok**
** WAS ACTIV3B ENROLLMENT GOAL INCREASED 20%***
NEW VIDEO ON ACTIV 3B VERY INTERESTING
BUT DOCTOR REPRESENTING NIH SAYS ENROLLMENT GOAL IS OVER 800????
JAVITT SAID 640 IN LAST PR, WHY NOW OVER 800? AM I MISSING SOMETHING??
** WAS ACTIV3B ENROLLMENT GOAL INCREASED 20%***
NEW VIDEO ON ACTIV 3B VERY INTERESTING
BUT DOCTOR REPRESENTING NIH SAYS ENROLLMENT GOAL IS OVER 800????
JAVITT SAID 640 IN LAST PR, WHY NOW OVER 800? AM I MISSING SOMETHING??
Soliloquy LIKE I SAID....
WONDER WHY THAT FUND WOULD SELL WHILE EVERYONE ELSE WAS BELIEVING
THE MISLEADING STATEMENTS JAVITT WAS MAKING TO EXPECT EUA
**** ISRAEL FUND SELLS NRX????***
INTERESTING TIMING ON THEIR SALE.... Q3 2021??? WHILE WE WERE BEING TOLD TO “EXPECT EUA” ISRAEL FUND SELLING?? WONDER WHY??
https://www.google.com/amp/s/finance.yahoo.com/amphtml/news/timothy-plan-israel-common-values-113802982.html
**** ISRAEL FUND SELLS NRX????***
INTERESTING TIMING ON THEIR SALE.... Q3 2021??? WHILE WE WERE BEING TOLD TO “EXPECT EUA” ISRAEL FUND SELLING?? WONDER WHY??
https://www.google.com/amp/s/finance.yahoo.com/amphtml/news/timothy-plan-israel-common-values-113802982.html
LOL NOW ITS BEFORE CHRISTMAS.....
NOTICE THE PATTERN????
GOAL LINE MOVED OVER AND OVER AND NEVER GET ANYTHING ACROSS
ASK YOURSELF WHY.....
@Jonathan_Javitt is withholding information from and REFUSING to be honest with shareholders...
JUST A FEW OF THE WITHHELD ITEMS: (there are MANY more)
#1 Status of Type A meeting
#2 Status of Georgia EUA
#3 Refusal to publish FDA denial
#4 Refusal to answer why Javitt listed as author on preprint wrote we had EUA approval in Ukraine, Caucus Region and India
#5 Refusal to disclose on what date they were first advised (directly or indirectly) That EUA’s & BTD Were going to be denied
#6 refusal to disclose on what date and why they hired a new statistician to re-analyze the data of Javitts botched trial yet again.
#7 Refusal to advise and disclose why they filed for a type a meeting a week before they supposedly were surprised by FDA denial
ASK YOURSELF WHY.....
@Jonathan_Javitt is withholding information from and REFUSING to be honest with shareholders...
JUST A FEW OF THE WITHHELD ITEMS: (there are MANY more)
#1 Status of Type A meeting
#2 Status of Georgia EUA
#3 Refusal to publish FDA denial
#4 Refusal to answer why Javitt listed as author on preprint wrote we had EUA approval in Ukraine, Caucus Region and India
#5 Refusal to disclose on what date they were first advised (directly or indirectly) That EUA’s & BTD Were going to be denied
#6 refusal to disclose on what date and why they hired a new statistician to re-analyze the data of Javitts botched trial yet again.
#7 Refusal to advise and disclose why they filed for a type a meeting a week before they supposedly were surprised by FDA denial
SO LET ME GET THIS STRAIGHT...
THE NATION OF GEORGIA APPROVED EUA ALMOST 5 MONTHS AGO BUT WAS SO IMPRESSED WITH ZYESAMI AND WANTED IT SO BAD THEY HAVE ORDERED A GRAND TOTAL OF ZERO DOSES!!!
JAVITT/NRX REFUSE TO ANSWER VALID QUESTIONS ABOUT WHAT THEY KNOW FROM FDA ABOUT TYPE A MEETING...
JAVITT/NRX REFUSE TO ANSWER WHEN THE STARTED THE NEW DATA ANALYSIS BY NEW STATISTICIAN?
JAVITT/NRX REFUSE TO SAY WHEN THEY FIRST NEW (in any way) THAT EUA’s & BTD WERE GOIN G TO BE DENIED
AND PEOPLE WONDER WHY @Jonathan_Javitt is thought to be a FRAUD LIAR!!
” SOON MANY OTHER NATIONS WILL FOLLOW HUH JON”???
SO LET ME GET THIS STRAIGHT...
THE NATION OF GEORGIA APPROVED EUA ALMOST 5 MONTHS AGO BUT WAS SO IMPRESSED WITH ZYESAMI AND WANTED IT SO BAD THEY HAVE ORDERED A GRAND TOTAL OF ZERO DOSES!!!
JAVITT/NRX REFUSE TO ANSWER VALID QUESTIONS ABOUT WHAT THEY KNOW FROM FDA ABOUT TYPE A MEETING...
JAVITT/NRX REFUSE TO ANSWER WHEN THE STARTED THE NEW DATA ANALYSIS BY NEW STATISTICIAN?
JAVITT/NRX REFUSE TO SAY WHEN THEY FIRST NEW (in any way) THAT EUA’s & BTD WERE GOIN G TO BE DENIED
AND PEOPLE WONDER WHY @Jonathan_Javitt is thought to be a FRAUD LIAR!!
” SOON MANY OTHER NATIONS WILL FOLLOW HUH JON”???
** NEW CHALLENGE **
SINCE NO ONE COULD WIN THE FIRST CHALLENGE OF FINDING EVIDENCE THAT TYPE A MEETING WAS ACCEPTED.... HERE IS NEW ONE... TRY AND FIND ANSWERS TO QUESTIONS BELOW... (hint you will be ignored by @Jonathan_Javitt and NRX WITHHOLDING INFO)
DEMAND TO KNOW THE LATEST ON THE TYPE A MEETING!!!!
DEMAND TO KNOW STATUS OF FDA DISCUSSION ABOUT 150 PATIENT DATA JAVITT WANTED TO SHOW THEM FROM BLINDED TRIAL
DEMAND TO KNOW IF FDA ACCEPTED JAVITT WANTING TO BRING IN DR’s ETC TO SPEAK TO FDA...
THE TRUTH IS OUT THERE... TRY AND GET ANSWERS AND YOU WILL SEE THEY ARE HIDING TRUTHS AND REFUSING TO ANSWER
Georgejjl.. I READ IT.. QUESTION....
HOW HAS THE MARKET REACTED SINCE THAT WAS PUT OUT??
**** NEW CHALLENGE *****
SINCE NO ONE COULD WIN THE FIRST CHALLENGE OF FINDING EVIDENCE THAT TYPE A MEETING WAS ACCEPTED.... HERE IS NEW ONE... TRY AND FIND ANSWERS TO QUESTIONS BELOW... (hint you will be ignored by @Jonathan_Javitt and NRX WITHHOLDING INFO)
DEMAND TO KNOW THE LATEST ON THE TYPE A MEETING!!!!
DEMAND TO KNOW STATUS OF FDA DISCUSSION ABOUT 150 PATIENT DATA JAVITT WANTED TO SHOW THEM FROM BLINDED TRIAL
DEMAND TO KNOW IF FDA ACCEPTED JAVITT WANTING TO BRING IN DR’s ETC TO SPEAK TO FDA...
THE TRUTH IS OUT THERE... TRY AND GET ANSWERS AND YOU WILL SEE THEY ARE HIDING TRUTHS AND REFUSING TO ANSWER
***** JAVITT KNEW WEEK BEFORE?******
HE FILE FOR A TYPE A DENIAL/STALLED PRODUCT MEETING AND DAYS LATER INTENTIONALLY MISLEAD PEOPLE BY SAYING EUA PENDING LIKE NOTHINGS WRONG KNOW FULL WELL YOU FILED FOR DENIED/STALLED PRODUCT MEETING DAYS BEFORE!!
***** JAVITT KNEW WEEK BEFORE?******
HE FILE FOR A TYPE A DENIAL/STALLED PRODUCT MEETING AND DAYS LATER INTENTIONALLY MISLEAD PEOPLE BY SAYING EUA PENDING LIKE NOTHINGS WRONG KNOW FULL WELL YOU FILED FOR DENIED/STALLED PRODUCT MEETING DAYS BEFORE!!
JAVITT HAD ANSWER OF TYPE A WITHIN 14 DAYS
WITHHOLDING INFO?????
https://www.google.com/amp/s/www.policymed.com/amp/2018/03/fda-issues-new-draft-guidance-on-submitting-formal-meeting-requests.html
JAVITT HAD ANSWER OF TYPE A WITHIN 14 DAYS
WITHHOLDING INFO?????
https://www.google.com/amp/s/www.policymed.com/amp/2018/03/fda-issues-new-draft-guidance-on-submitting-formal-meeting-requests.html
**** INTERESTING QUESTION*****
FDA GUIDELINES.... WHAT SAY YOU DR DECEIT????
WE ARE PAST 30 DAYS!!! ALSO WHY REQUEST A MEETING THEN LEAD PEOPLE TO BELIEVE THERE ARE NO PROBLEMS WITH EUA?? THEN SAY YOU WERE SURPRISED BY EUA DENIAL... UM DID YOU NOT ALREADY REQUEST DENIAL MEETING??
Type A meetings should be scheduled to occur within 30 days of FDA receipt of a written meeting request.
JON..... WHY WAS THE PRODUCT “stalled” WHEN YOU REQUESTED THE MEETING THE LAST WEEK OF OCTOBER????
BUT THEN YOU SAY DAYS LATER TO SHAREHOLDERS THAT EUA IS PENDING (MISLEADING LIKE NOTHING IS WRONG)
A Type A meeting is a meeting needed to help an otherwise stalled product development program proceed. Examples of a Type A meeting include:
• Dispute resolution meetings as described in 21 CFR 10.75, 312.48, and 314.103 and in 3 the guidance for industry Formal Dispute Resolution: Appeals Above the Division Level
• Meetings to discuss clinical holds in which a response to hold issues has been submitted, but the FDA and the sponsor or applicant agree that the development is stalled and a new path forward should be discussed
• Special protocol assessment meetings that are requested by sponsors or applicants after receipt of FDA evaluation of protocols under the special protocol assessment procedures as described in the guidance for industry Special Protocol Assessment
**** INTERESTING QUESTION*****
FDA GUIDELINES.... WHAT SAY YOU DR DECEIT????
WE ARE PAST 30 DAYS!!! ALSO WHY REQUEST A MEETING THEN LEAD PEOPLE TO BELIEVE THERE ARE NO PROBLEMS WITH EUA?? THEN SAY YOU WERE SURPRISED BY EUA DENIAL... UM DID YOU NOT ALREADY REQUEST DENIAL MEETING??
Type A meetings should be scheduled to occur within 30 days of FDA receipt of a written meeting request.
JON..... WHY WAS THE PRODUCT “stalled” WHEN YOU REQUESTED THE MEETING THE LAST WEEK OF OCTOBER????
BUT THEN YOU SAY DAYS LATER TO SHAREHOLDERS THAT EUA IS PENDING (MISLEADING LIKE NOTHING IS WRONG)
A Type A meeting is a meeting needed to help an otherwise stalled product development program proceed. Examples of a Type A meeting include:
• Dispute resolution meetings as described in 21 CFR 10.75, 312.48, and 314.103 and in 3 the guidance for industry Formal Dispute Resolution: Appeals Above the Division Level
• Meetings to discuss clinical holds in which a response to hold issues has been submitted, but the FDA and the sponsor or applicant agree that the development is stalled and a new path forward should be discussed
• Special protocol assessment meetings that are requested by sponsors or applicants after receipt of FDA evaluation of protocols under the special protocol assessment procedures as described in the guidance for industry Special Protocol Assessment
WELL SAID BILL B
JUST LIKE I HAVE BEEN SAYING FOR A YEAR!!!!
Penny I read them all
If I understood them, He is claiming that HE trademarked RLF-100
and that Relief knew from day one they (NRX) was not using Reliefs formula but using
Sami Said’s and the SUNY license....
**** TYPE A MEETING IDEA****
Hmmmmm
HMMMM “DR” Deceit aka Jonathan_Javitt SURE has stuck his head in the sand AGAIN and went RADIO SILENT while awaiting another FDA decision.... his history is to do this exact thing EVERY SINGLE DENIAL BEFORE ( 2 EUA’s and BTD)
WHY NO UPDATE ON TYPE A MEETING JON?? WHAT HAS FDA TOLD YOU ALREADY?
my guess..... FDA DENIED MEETING or SAID THEY WOULD NOT CONSIDER THE 150 PATIENT DATA OR HEAR FROM THE DOCTORS JAVITT WANTED THEM TO!! LETS SEE IF IM RIGHT yet again!!
**** TYPE A MEETING INFO****
Hmmmmm
HMMMM “DR” Deceit aka Jonathan_Javitt SURE has stuck his head in the sand AGAIN and went RADIO SILENT while awaiting another FDA decision.... his history is to do this exact thing EVERY SINGLE DENIAL BEFORE ( 2 EUA’s and BTD)
WHY NO UPDATE ON TYPE A MEETING JON?? WHAT HAS FDA TOLD YOU ALREADY?
my guess..... FDA DENIED MEETING or SAID THEY WOULD NOT CONSIDER THE 150 PATIENT DATA OR HEAR FROM THE DOCTORS JAVITT WANTED THEM TO!! LETS SEE IF IM RIGHT yet again!!
***** TYPE A MEETING INFORMATION ****
HEY “DR” Javitt WHY NO UPDATE ON TYPE A MEETING....
FDA DECISION IS OVERDUE.... Hmmmm sensing a pattern ??
9/17/20 EUA DECISION “DELAYED“ and notice to shareholders withheld ended in denial
5/31/21 EUA DECISION “DELAYED“ and notice to shareholders withheld ended in denial
BTD DECISION “DELAYED“ and notice to shareholders withheld ended in denial
NOW TYPE A MEETING DECISION “DELAYED” NO FURTHER INFO AFTER JAVITT TRIED TO “appease” (mislead) INVESTORS.... GIVEN THE ABOVE HISTORY DID FDA REFUSE TYPE A MEETING OR WAS IT A BUST AND JAVITT IS USING HIS NORMAL WITHHOLDING INFORMATION
***** TYPE A MEETING INFORMATION ****
HEY “DR” Javitt WHY NO UPDATE ON TYPE A MEETING....
FDA DECISION IS OVERDUE.... Hmmmm sensing a pattern ??
9/17/20 EUA DECISION “DELAYED“ and notice to shareholders withheld ended in denial
5/31/21 EUA DECISION “DELAYED“ and notice to shareholders withheld ended in denial
BTD DECISION “DELAYED“ and notice to shareholders withheld ended in denial
NOW TYPE A MEETING DECISION “DELAYED” NO FURTHER INFO AFTER JAVITT TRIED TO “appease” (mislead) INVESTORS.... GIVEN THE ABOVE HISTORY DID FDA REFUSE TYPE A MEETING OR WAS IT A BUST AND JAVITT IS USING HIS NORMAL WITHHOLDING INFORMATION
******* GREAT IDEA ********
SINCE “DR” Jonathan_Javitt refuses to be honest and transparent with shareholders..
MAYBE NOW IF WE CONTACT THE FDA THEY WILL PROVIDE US WITH A PUBLIC LETTER, LIKE THEY DID WITH CYDY, explaining ALL the reasons the EUA & BTD was denied....
They have set a precedent by doing so with CYDY, a drug they ALSO said they would still “work with the company on” (so no conflict on)..... TOGETHER OUR VOICE IS LOUD... let’s finally get the truths being withheld from us!!!
******* GREAT IDEA ********
SINCE “DR” Jonathan_Javitt refuses to be honest and transparent with shareholders..
MAYBE NOW IF WE CONTACT THE FDA THEY WILL PROVIDE US WITH A PUBLIC LETTER, LIKE THEY DID WITH CYDY, explaining ALL the reasons the EUA & BTD was denied....
They have set a precedent by doing so with CYDY, a drug they ALSO said they would still “work with the company on” (so no conflict on)..... TOGETHER OUR VOICE IS LOUD... let’s finally get the truths being withheld from us!!!
***** EXCELLENT POST *****
SHAME ON YOU JON, ENJOY YOUR THANKSGIVING WITH ALL YOUR PRECIOUS NEW WEALTH, because your greed and endless misleading statements have cost MANY PEOPLE to NOT HAVE LOVED ONES AT THEIR TABLES... and I’m sure caused endless financial issues for many.. but hey at least You, Your brother, your sister, and your son have wealth at the cost of the above mentioned!!!
The latest CEO UPDATE from @Jonathan_Javitt EXPOSES HIM COMPLETELY AS AN UTTER FAILURE WHO WAS MORE INTERESTED IN ENRICHING HIMSELF, HIS FAMILY AND HIS FRIENDS THAN ACTUALLY SAVING PROPLE WHO ARE FIGHTING FOR THEIR LAST BREATH...
YOU WOULD HAVE THOUGHT AFTER RECEIVING NOT ONE... BUT TWO FDA EUA DENIALS THAT THE BTD APPLICATION WOULD HAVE HAD MORE INFORMATION THAN WHAT THE FDA WANTED, NOT LESS!!!!
JAVITT HAS MISLEAD EVERYONE FOR SO LING I BET HE NOW BELIEVES HIS LIES AS TRUTH, but the FDA is harder to fool than investors who only have access to limited information!!!
SHAME ON YOU JON!!!