After receiving the latest NRX news release regarding the cancellation of further trials due to the failure of Aviptadil and remembering that India actually issued an EUA for this very same drug, I knew that something was different somewhere. So I decided to contact one of the several doctors in India who were directly involved with the testing of Aviptadil. The Dr preferred to not be named and I will respect that, but I can say that the Dr was one of many who was at the top of the testing process. The Dr was kind enough to answer my questions although the Dr did not directly address as to why the US recent DSMB testing was labeled as "futile." The Dr did indicate that after a certain length of time if Aviptadil is not helping covid recovery, then "other" health factors could be the causation of death. Or, that is at least my understanding of the Dr's response and I could be misunderstanding some of it. As far as the DSMB statement goes, I am sure that not much can be said because the Dr. has no access to US testing data that was reviewed by the US DSMB.
I will share here and will lay it out in this order: My first introductory email to the Dr and the Dr's first response. Then below that will be my next response email to the Dr and the Dr's final response.
It is apparent to me at least that a different approach to testing as well as the target goals of the testing plus the duration of the testing may be the difference that caused the US DSMB to be so negative and different from the testing and results performed by India's health agencies. We will have to wait and see if NRX studies the US results and provides any comments or explanations to all of us shocked shareholders. I hope so... They owe us that much at the very least.
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26 May 2022
Dear Dr. XXXXXXX
I am reaching out to you in regard to the approval of Aviptadil in India. I am a shareholder of NRP and RLFTF. As you may already know, we have been notified that the DSMD has cancelled testing in the US of Aviptadil because they basically said it is worthless.
We shareholders are surprised and shocked. We have no idea as to why they made this decision. Previous studies fully indicated that this drug functioned well and saved lives. We had been waiting for a US EUA.
I know you are probably very busy, but if you would kindly offer your opinion as to why you think this has happened I would really appreciate your thoughts.
I read that India approved your EUA for this drug and I know that you also have stringent requirements. India is a leader in medical research. So I am just wondering what the difference may be.
Thank you so much for any info or opinion on this subject.
Take care!
Bob
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27 May 2022
In a message dated 5/27/2022 12:38:56 AM Pacific Standard Time, xxxxxxxx writes:
Dear Bob,
Aviptadil is a highly effective drug and it can reverse the ARDS (Acute respiratory distress syndrome) condition promptly. If you look at the USFDA website you'll find that USFDA has approved Vasoactive intestinal peptide (Aviptadil) as an orphan drug for acute respiratory distress syndrome. Aviptadil is also approved as an orphan drug by FDA for Pulmonary hypertension, which is a condition directly linked to ARDS. The same has also been approved by EMA (European Medical agency). Another condition directly linked to ARDS is Acute lung injury, which is also an orphan drug status approved indication for Aviptadil in both the regions.
We have found excellent results of the drug during clinical trials in Indian patients.
Indian Drug regulatory agencies with help of their Subject expert committees scrutinized the clinical trial data for several months and had several review meetings for the scientific discussions with us before granting the EUA permission.
Our clinical trial, is under publication and will come online by first week of June.
Hope the above information is helpful to you.
Kind Regards
Dr. XXXXXXXX
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27 May 2022
Dear Dr XXXXXXXX,
Thank you so very much for your response to my question. I appreciate you taking the time out of your busy day!
As I mentioned, I am a shareholder with NRXP and RLFTF. They both for some time now have been trying to obtain a US EUA. Then last Wednesday we all received a News Release from NRX announcing the cancellation of further testing because the DMSB said Aviptadil did no better than the placebo results. We are confused and shocked because earlier test results showed, just as you have also indicated that Aviptadil saves lives. We have no idea as to why the test results for this current testing were are they were reported.
I posted the news release and the link below. If you have time, can you review the data and provide your opinion on this please? I am saddened mostly because people are dying when all this time Aviptalil could have prevented much of that loss.
And out of respect, am I free to share your opinion on this subject?
Once again I sincerely thank you for responding!
I wish you all the best and take care!
Bob
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28 May 2022
NOTE: The Dr approved release but prefers to remain anonymous.
Dear Mr. XXXXXXX,
Scientifically speaking the effect of Aviptadil needs to be observed for the first week only (Acute phase), which is most critical period for saving life of patient. After that other factors become overwhelming in deciding the outcome of the patient's condition. Immediate improvement in oxygen saturation is the clear cut proof of it. In simpler words, since aviptadil is a short acting drug, we either need to infuse it repeatedly or give through nebulizer for managing a chronic condition. The clinical trials in Covid-19 shouldn't have focused on the clinical outcome longer than 1 week outcome after aviptadil infusion, other wise repeated doses need to be given.
Even in our clinical trial, the quick relief from the symptoms has lead to the long term improvement in clinical condition, since the "Standard of care" was being given along with for long term management.
The PO2:FiO2 ratio starkly improved on day2 onwards and that played a major role in overall clinical improvement. The critical level is 100, once the patient achieves level above 100 for the ratio, generally the survival becomes better, and same was observed in our clinical trial.
Kind Regards
Dr. XXXXXXXXX
