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Hansje

Great news Yammy. Mexico is a bit far from Europa but I can live with that! Will travel there as soon as I'm incluced in the next trial.

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OFMDH
1 hour ago, Hansje said:

Great news Yammy. Mexico is a bit far from Europa but I can live with that! Will travel there as soon as I'm incluced in the next trial.

Mexico requires mexican citizens to participate in their trials. 

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OFMDH
3 minutes ago, Hansje said:

That is very bad news for non-Mexicans. 

No, it doesn't mean they're going to do a trial in Mexico. This could simply mean that Vitel in Mexico will do the blood work for another trial in St. Kitts.

Edited by OFMDH

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Hansje

I would have considered getting the Mexican nationality but that probably isn't very easy to do.

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Hopeful4Cure
7 hours ago, OFMDH said:

No, it doesn't mean they're going to do a trial in Mexico. This could simply mean that Vitel in Mexico will do the blood work for another trial in St. Kitts.

I believe it means that Vitel in Mexico is going to manufacture the vaccine and then, I predict, Dr. Halford is going to open various clinics throughout Mexico so citizens of any country can travel there and receive the vaccine directly.  He is highly motivated to make this vaccine accessible to all sufferers and circumvent the US FDA road block.  He is cutting edge and realizes that this is a global market.  People can and should make important health care and treatment choices for themselves.

 
0bf36b89ab4dbabc0223950942286714?s=48&d=

October 3, 2016 at 6:14 am

REPLY

Hi Hope,

Reasonable question ["So what are the chances a vaccine for HSV could get fast track, breakthrough therapy, accelerated approval, or priority review status from the FDA? And would you consider pushing for some expedited approval process to bring your vaccine to market faster than usually required?"], which I will address in late October. You assume that I plan to play by the rules of the regressive US FDA. However, 95% of the world does not live under the FDA’s jurisdiction. I will focus on eradicating herpes outside of the USA, and later on the FDA can figure out whether or not U.S. citizens should have access to the vaccine without having to hop on a plane or a cruise ship (i.e., international law takes precedence 12 nautical miles offshore of Miami or Los Angeles). Not planning to wait 10 years to run clinical trials or start sales.
If this seems outlandish, please remember that the live VZV Oka vaccine that has effectively started eradicating chickenpox was first described in Japan in 1974, used in the Japanese population for 15 years, and only then did Merck purchase, and bring back to the USA, with deployment finally starting in 1995.
Uber did not succeed by playing by Yellow Cab’s rules, and RVx does not plan to succeed by playing by the FDA’s rules that only apply to 5% of the world’s population. It’s up to you whether or not you are willing to travel, and I am perfectly happy to start eradicating herpes in South America rather than North America.
– Bill H.

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Hopeful4Cure
18 minutes ago, Hopeful4Cure said:

I believe it means that Vitel in Mexico is going to manufacture the vaccine and then, I predict, Dr. Halford is going to open various clinics throughout Mexico so citizens of any country can travel there and receive the vaccine directly.  He is highly motivated to make this vaccine accessible to all sufferers and circumvent the US FDA road block.  He is cutting edge and realizes that this is a global market.  People can and should make important health care and treatment choices for themselves.

 

0bf36b89ab4dbabc0223950942286714?s=48&d=

October 3, 2016 at 6:14 am

REPLY

Hi Hope,

Reasonable question ["So what are the chances a vaccine for HSV could get fast track, breakthrough therapy, accelerated approval, or priority review status from the FDA? And would you consider pushing for some expedited approval process to bring your vaccine to market faster than usually required?"], which I will address in late October. You assume that I plan to play by the rules of the regressive US FDA. However, 95% of the world does not live under the FDA’s jurisdiction. I will focus on eradicating herpes outside of the USA, and later on the FDA can figure out whether or not U.S. citizens should have access to the vaccine without having to hop on a plane or a cruise ship (i.e., international law takes precedence 12 nautical miles offshore of Miami or Los Angeles). Not planning to wait 10 years to run clinical trials or start sales.
If this seems outlandish, please remember that the live VZV Oka vaccine that has effectively started eradicating chickenpox was first described in Japan in 1974, used in the Japanese population for 15 years, and only then did Merck purchase, and bring back to the USA, with deployment finally starting in 1995.
Uber did not succeed by playing by Yellow Cab’s rules, and RVx does not plan to succeed by playing by the FDA’s rules that only apply to 5% of the world’s population. It’s up to you whether or not you are willing to travel, and I am perfectly happy to start eradicating herpes in South America rather than North America.
– Bill H.

KILL QUEEN  MAB 
ef4781a621d8e23779e98cc29e59c94e?s=48&d=

Mexico: Tijuana via San Diego. Nogales via Tucson. Juarez via El Paso. Laredo via San Antonio.

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Hopeful4Cure

What was the telling clue you are referring to in his blog?  Are you saying that St. Kitts will allow him to sell his vaccine but Mexico will not?  Blink once for yes and twice for no!

Too much pain, physical and psychological, is experienced with this disease.  As tears stream down my face, please let me know where I am travelling to and when? Please...

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dont quit!17

If Halford wants to sell his vaccine in Mexico it shouldn't be an issue. I go there frequently and buy ABX, antivirals, hormone supplements, Vitamin B 12 supplements without prescription. Mexico would appreciate the tourism and money spent there. I really hope he sells it there being that I live 2 hours from border.

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Hansje

Glad for you! (if you can actually get it there which we don't know yet)

For me Mexico or St. Kitts is about the same. Maybe Mexico would be a cheaper ticket

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OFMDH
1 hour ago, Hopeful4Cure said:

What was the telling clue you are referring to in his blog?  Are you saying that St. Kitts will allow him to sell his vaccine but Mexico will not?  Blink once for yes and twice for no!

Too much pain, physical and psychological, is experienced with this disease.  As tears stream down my face, please let me know where I am travelling to and when? Please...

https://liveherpesvaccine.com/#comment-4176  

 

Quote

Are you saying that St. Kitts will allow him to sell his vaccine but Mexico will not?

No. Testing in St. Kitts is easier, but that doesn't mean he can sell there. For Mexico if you're not already approved somewhere you need their local version of FDA (its called COFEPRIS) to approve testing of it and eventually show you're making a clinical version of the drug. Right now Halford is simply in research grade and as far as I know still needs to get COFEPRIS to approve any testing in Mexico. They are far off from mass manufacturing a clinical grade version of any drug vaccine version. 

Quote

please let me know where I am travelling to and when? Please...

If you're in a trial it will be St. Kitts. Mexico requires indigenous participants. If he does trials in Mexico and something eventually gets approved, then you could buy something there - but that is at least 2-3 years off in the future; I'd wager its more like 7-10 years as things are figured out. 

Edited by OFMDH

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Chin up31
8 hours ago, OFMDH said:

https://liveherpesvaccine.com/#comment-4176  

 

No. Testing in St. Kitts is easier, but that doesn't mean he can sell there. For Mexico if you're not already approved somewhere you need their local version of FDA (its called COFEPRIS) to approve testing of it and eventually show you're making a clinical version of the drug. Right now Halford is simply in research grade and as far as I know still needs to get COFEPRIS to approve any testing in Mexico. They are far off from mass manufacturing a clinical grade version of any drug vaccine version. 

If you're in a trial it will be St. Kitts. Mexico requires indigenous participants. If he does trials in Mexico and something eventually gets approved, then you could buy something there - but that is at least 2-3 years off in the future; I'd wager its more like 7-10 years as things are figured out. 

@OFMDH if Mexico is 2- 3years off at the least if approved and St.Kitts might be a unsure question mark when it comes to mass sales besides doing trials there..So when Halford said the Theravax will be available next year what did he mean by that?

Thanxs ahead of time

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Hansje

Here it is:

CRAZYHORSE 
e9fceb1ec35c8682b9178381335a0277?s=48&d=

why not just charter or rent a large vessel, sail it into international waters and drop anchor…that ship would be for all intents and purposes another country…then contract another boat to act as a shuttle…seems plausible to me

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https://liveherpesvaccine.com/2016/10/17/next-steps/

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Chin up31
3 hours ago, OFMDH said:

This is a guy saying screw NIH and the FDA, so he has little respect for regulatory bodies. 

What he has said is a comment about going into international waters if he cannot get a country to approve it. 

So regardless how good Theravax is if not approved in no country means no distribution sale i guess.

Whats the chances of going into international waters on vessel Has someone did this before?

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Constant Diplomat
22 hours ago, Hopeful4Cure said:

U.S. citizens should have access to the vaccine without having to hop on a plane or a cruise ship (i.e., international law takes precedence 12 nautical miles offshore of Miami or Los Angeles).

Herpes cruise ship would be fun. The Simplex Swingers Boat.

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zzzqzzz
20 hours ago, OFMDH said:

If you're in a trial it will be St. Kitts. Mexico requires indigenous participants. If he does trials in Mexico and something eventually gets approved, then you could buy something there - but that is at least 2-3 years off in the future; I'd wager its more like 7-10 years as things are figured out. 

Just wondering, where are you getting your time estimates from?

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Seeker1960

Halford is going to be successful. If Halford believed in the process he would go with it. Look at all the drugs they push on TV and the disclaimers with them. Most of them have terrible side effects and are super expensive. They all have FDA approval though.

I will take my chances with Halford over big Pharma and the FDA. He is on the right track and has the right approach. Its going to be the St Kitts buyers club.

Edited by Seeker1960

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OFMDH

@zzzyzzz the first estimate is based on a realistic timeline for a new drug in Mexico that isn't approved anywhere else; meetings, trials, etc. The longer number of 7-10 years is my opinion what is actually likely to happen to Hanford.

 

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Chin up31
2 hours ago, OFMDH said:

@zzzyzzz the first estimate is based on a realistic timeline for a new drug in Mexico that isn't approved anywhere else; meetings, trials, etc. The longer number of 7-10 years is my opinion what is actually likely to happen to Hanford.

 

@OFMDH makes sense logically in regards to Mexico.This has been one hell of roller coaster ride following Halford progress and hard work i HOPE it doesn't end this way.i regard a lot of your knowledge and research in this field also,so in  your honest opinion is Halford is bullshiting us?y/n would be fine or maybe Halford & RX has a trick up their sleeves to make this happen next year that maybe your not aware of?

"Not impossible" but i find it hard to believe a person with his intellect and career on the line is really bullshiting millions of us suffers world wide so boldly by his comments of Theravax  next year availability unless this is some big cruel psychopathic joke being played on a large scale.nevertheless am gonna live my life

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