Craigakess, I understand your frustration. H
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Posted On: 11/08/2020 8:21:47 AM
Re: craigakess #64566
Craigakess,
I understand your frustration.
However, bear in mind that we have a high frequency of CC's , therefore the new earth-chattering news by definition reduce as we are relatively very well informed.
I invite you to mentally go into a company where the company "talks to you" every year or so, and when they do, their language is as clear as mud. Yes their CEO's are very smart PHDs from ivy league universities and will tell you: " we are advancing swiftly with our excellent clinical programs in a symbiotic landscape where we are leveraging our natural strengths in a result-oriented habitat but yet we expect our investors to have more forbearance as research doesn't normally results in paroxysms of clinical developments". Believe me, I can give you a list of companies that do not say anything for extended periods of time, worse, companies with only one shot at goal. One does not hear from them "ever".
Well, no thanks. I prefer NP's accented English and sometimes exuberance. Why? It gives me information (positive or negative) so I can make decisions on my investment.
So, yes I was informed and updated in the last CC. Some here have posted excellent summaries, but let me share my takeaways (surely a repetition of what has been posted), not exactly what was said, as they are MY takeaways:
1) The LH protocol is being worked on. Probably will be 100 patients in a 1:1 ratio. It will be a 8 weeks study.
2) The shelf life of LL is long. When at -80 DegC is many years. The 1.44mL vial has a two year life and at room temperature is 48 hours.
3) In talks with FDA regarding mono trial. Maybe we will start from a clean start.
4) NP believes what myself and others have been saying for long. We get approved for ONE indication and the dam will fall. There will be extensive off-label usage and back to back to back approvals (NP words).
5) Immunomodulation indications for LL are incredible promising. We should remember Humira and NP's famous words few years back when we were a 30 something cents company: we will be the next Humira.
6) The market for PrEP is very large: we are expecting a once a month injection with a price of $20K and according to NP 187K patients used a drug in 2018 ($3.74 Billion market )
7) After all we had discussions with OWS (Dr. Janet Woodcock), was surprised that NP didn't even mentioned it as part of the main body of the CC and only said so during the Q&A section. This is big as there might be need for accelerated production and funds for this.
We are exploring the myocarditis indication.
9) We are focusing on completing our 293 enrollment, have 250 or so already enrolled.
10) BLA submission for U.K. being worked on
11) Hoping to enroll patients for NASH this year (this is a humongous indication).
12) HIV cure attempt is ongoing. 2 Potential patients died. Looking for candidates.
I understand your frustration.
However, bear in mind that we have a high frequency of CC's , therefore the new earth-chattering news by definition reduce as we are relatively very well informed.
I invite you to mentally go into a company where the company "talks to you" every year or so, and when they do, their language is as clear as mud. Yes their CEO's are very smart PHDs from ivy league universities and will tell you: " we are advancing swiftly with our excellent clinical programs in a symbiotic landscape where we are leveraging our natural strengths in a result-oriented habitat but yet we expect our investors to have more forbearance as research doesn't normally results in paroxysms of clinical developments". Believe me, I can give you a list of companies that do not say anything for extended periods of time, worse, companies with only one shot at goal. One does not hear from them "ever".
Well, no thanks. I prefer NP's accented English and sometimes exuberance. Why? It gives me information (positive or negative) so I can make decisions on my investment.
So, yes I was informed and updated in the last CC. Some here have posted excellent summaries, but let me share my takeaways (surely a repetition of what has been posted), not exactly what was said, as they are MY takeaways:
1) The LH protocol is being worked on. Probably will be 100 patients in a 1:1 ratio. It will be a 8 weeks study.
2) The shelf life of LL is long. When at -80 DegC is many years. The 1.44mL vial has a two year life and at room temperature is 48 hours.
3) In talks with FDA regarding mono trial. Maybe we will start from a clean start.
4) NP believes what myself and others have been saying for long. We get approved for ONE indication and the dam will fall. There will be extensive off-label usage and back to back to back approvals (NP words).
5) Immunomodulation indications for LL are incredible promising. We should remember Humira and NP's famous words few years back when we were a 30 something cents company: we will be the next Humira.
6) The market for PrEP is very large: we are expecting a once a month injection with a price of $20K and according to NP 187K patients used a drug in 2018 ($3.74 Billion market )
7) After all we had discussions with OWS (Dr. Janet Woodcock), was surprised that NP didn't even mentioned it as part of the main body of the CC and only said so during the Q&A section. This is big as there might be need for accelerated production and funds for this.
We are exploring the myocarditis indication. 9) We are focusing on completing our 293 enrollment, have 250 or so already enrolled.
10) BLA submission for U.K. being worked on
11) Hoping to enroll patients for NASH this year (this is a humongous indication).
12) HIV cure attempt is ongoing. 2 Potential patients died. Looking for candidates.
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