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To Senator Lekpin
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| Chancellor_Kruus | Date: Saturday, 05 April 14, 8:11 PM | Message # 1 |
 Colonel
Group: Users
Messages: 200
Status: Offline
| Dear Sir,
The Trade Commission requires a sample of this new chemical you wish to market produced on Drongar named "Bota"
Around 100g should be all we require to run tests to check for it's safety profile, however, if you wish to market this for sentient consumption you will be required to gain a license to do so.
(Signed with the Seal of the Trade Commission)
Chancellor Luneray Kruus
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Supreme Chancellor of the Galactic Republic
President of the Senate &c
Representative of the People of the Humbarine Sector
Trade Baron
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| Roman_Lekpin | Date: Saturday, 05 April 14, 9:21 PM | Message # 2 |
 Lieutenant colonel
Group: Users
Messages: 112
Status: Offline
| Mr. Kruus,
You'll have the sample quite soon, the ways things are looking. As well, we will need to have the license issued as quickly as possible.
Regards,
Roman Lekpin
Former Senator, Lorrd (100 BBY-92 BBY)
Chosen of House Garth
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| Chancellor_Kruus | Date: Saturday, 05 April 14, 9:26 PM | Message # 3 |
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Colonel
Group: Users
Messages: 200
Status: Offline
| A license as what? A medication or a generally available foodstuff? The Trade Council isn't aware of the details of the product but perhaps you can illuminate us.
Chancellor Luneray Kruus
______________
Supreme Chancellor of the Galactic Republic
President of the Senate &c
Representative of the People of the Humbarine Sector
Trade Baron
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| Roman_Lekpin | Date: Saturday, 05 April 14, 9:36 PM | Message # 4 |
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Lieutenant colonel
Group: Users
Messages: 112
Status: Offline
| It isn't a food item, Mr. Kruus. It is a medical item.
Roman Lekpin
Former Senator, Lorrd (100 BBY-92 BBY)
Chosen of House Garth
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| Chancellor_Kruus | Date: Saturday, 05 April 14, 10:04 PM | Message # 5 |
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Colonel
Group: Users
Messages: 200
Status: Offline
| The Process for Approval as a Pharmaceutical is the following, unless there is an express need and urgency in which procedure may be waived.
1. Safety testing and profiling by the appointed lab of the Trade Council. While these are carried out the new chemical will be placed on a Provisional Control Status banning it's trade, supply or distribution of the drug for anything but Research inside the Republic. After testing it will be assigned a status based on it's projected usefulness, any threat of abuse etc and it will be assigned a control category from "Inert" up to "Prohibited" depending on it's profile.
2. Application for a License to Provisionally Distribute a New Medicine, this must include non-sentient clinical trials and their results.
3. The License to Provisionally Distribute a New Medicine will allow you to send the medicament to Sentient Clinical Trial, at least three of these must be conducted and their outcomes published by a peer-reviewed Journal.
4. If a favourable outcome is achieved the Trade Council Pharmacological Subcommittee will review the data, and if the chemical is safe and effective it may be granted a License to Distribute a New Medicine and it officially to be classed as a medical drug. If it has been approved as a Medication its control status will be reviewed but it will be made unconditionally legal with a prescription from a formally licensed qualified physician.
Chancellor Luneray Kruus
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Supreme Chancellor of the Galactic Republic
President of the Senate &c
Representative of the People of the Humbarine Sector
Trade Baron
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| Roman_Lekpin | Date: Saturday, 05 April 14, 10:20 PM | Message # 6 |
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Lieutenant colonel
Group: Users
Messages: 112
Status: Offline
| Lorrd has already undertaken medical studies at its excellent facilities on Lorrd, but once again, Mr. Kruus, let's get all of this started. The sooner the better, you know? The Republic can benefit greatly from this medical source.
Roman Lekpin
Former Senator, Lorrd (100 BBY-92 BBY)
Chosen of House Garth
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| Chancellor_Kruus | Date: Saturday, 05 April 14, 10:30 PM | Message # 7 |
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Colonel
Group: Users
Messages: 200
Status: Offline
| I appreciate this. But for me to circumvent procedure you need to demonstrate there is an urgent and demonstrable need for it to go straight to market. You're telling us so much about why you need to be able to trade in this drug but no actual detail as to what it is and why we need to grant it license so urgently?
Chancellor Luneray Kruus
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Supreme Chancellor of the Galactic Republic
President of the Senate &c
Representative of the People of the Humbarine Sector
Trade Baron
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| Roman_Lekpin | Date: Saturday, 05 April 14, 10:42 PM | Message # 8 |
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Lieutenant colonel
Group: Users
Messages: 112
Status: Offline
| To begin, there have been no ill effects in six months of prior study of bota. You may not know it, but bota is hardly new to the galaxy, Mr. Kruus. Small-time harvesters having been bringing it off of Drongar for years. Bota is a very useful across the entire species line. There have been no fatal side effects of bota on any known species, and it has been proven that bota is the only drug capable of dealing with the extremely deadly smashbone fever.
By not bringing this into production, you can be costing lives. I can understand the need for procedure, but there is also a reason why Lorrd is willing to grant a large portion of all harvests for free to Republic medical centers.
Roman Lekpin
Former Senator, Lorrd (100 BBY-92 BBY)
Chosen of House Garth
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| Chancellor_Kruus | Date: Saturday, 05 April 14, 11:03 PM | Message # 9 |
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Colonel
Group: Users
Messages: 200
Status: Offline
| Just because a substance has been sold without license as a medicine (making it's sale illegal) doesn't mean I know about it.
Senator, please clarify, is the fact that you are donating 25% of your profits to the Republic meant to sway the committee to speed your drug's route to the market?
As I say, as soon as we have a sample we can think about factors which might persuade us to get it to market. Until then, we cannot rush the processes which are there to protect patients. I am shocked that your Doctors allowed a shady offworld substance to be used even in trials.. but worlds vary in their approach.
Chancellor Luneray Kruus
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Supreme Chancellor of the Galactic Republic
President of the Senate &c
Representative of the People of the Humbarine Sector
Trade Baron
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| Roman_Lekpin | Date: Saturday, 05 April 14, 11:37 PM | Message # 10 |
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Lieutenant colonel
Group: Users
Messages: 112
Status: Offline
| If you noticed, I was willing to donate 25% of the substance, not the profits, to the Republic. This was decided long before I knew about this process.
I'm surprised you call it shady, though with the known effect it has on Neimoidians, I'm a little surprised.
If anything, Mr. Kruus, I think you'll find it to have certain properties that surpass bacta in some regards.
Roman Lekpin
Former Senator, Lorrd (100 BBY-92 BBY)
Chosen of House Garth
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