Traxion Sab De Cv Ord Shs GRPOF

Tetra Bio-Pharma provides update on status of its Phase 3

[TheBossCwC]

Tetra Bio-Pharma provides update on status of its Phase 3 Clinical Trial Application of Lead Drug Candidate PPP001
09 December, 2017 OTTAWA, ONTARIO -- (Marketwired) -- 12/09/17 -- Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX VENTURE:TBP)(OTCQB:TBPMF), a global leader in cannabinoid-based drug development, announced today that the Company has accepted the suggestion of Health Canada to change the order of its clinical trial application (CTA) review process. As such, the quality certification for the manufacturing of PPP001 will take place prior to the approval of its clinical trial protocol as Health Canada assesses its partner Aphria's operations for Good Manufacturing Practices (GMP) for pharmaceutical products. Tetra agrees to this change from Health Canada because it is in the best interest of patients.
This change in the usual CTA approval process is expected to potentially extend the review process by 30 days. Tetra continues to expect PPP001 to become the first cannabis-derived inhalation drug to receive a drug identification number (DIN) from Health Canada, as well as pharmaceutical drug status from the FDA. The phase 3 trial should therefore begin in early 2018. The Company expects this change to have only a minor impact on time to market for PPP001.
Tetra received approval for the ethics review board on November 6th and subsequently submitted a Clinical Trial Application (CTA) for its Phase 3 clinical trial in cancer patients. This trial is expected to be a landmark clinical trial and is the first of its kind, enrolling a total of 946 subjects. Dr Guy Chamberland, Tetra's Chief Scientific Officer (CSO) commented that: "a GMP certification from Health Canada's drug inspectorate is welcome as this certification will signal to the company that its manufacturing partners comply with GMP requirements for drug approval and increases the measures put in place to ensure patients' safety." Once the trial is initiated, The Company will accelerate enrolment by expanding the number of clinical sites as it aims to adhere to its target date for filing PPP001 as a prescription drug (with a drug identification number - DIN) to Health Canada.
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX VENTURE:TBP)(OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products.
More information at: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-looking statements
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words "may", "will", "should", "continue", "expect", "anticipate", "estimate", "believe", "intend", "plan" or "project" or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company's ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a licence for the production of medical marijuana; failure to obtain sufficient financing to execute the Company's business plan; the success of the Rx Princeps product offering and inhalation device; guidance on expected sales volumes associated with the Rx Princeps product offering and inhalation device; competition; regulation and anticipated and unanticipated costs and delays, and other risks disclosed in the Company's public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.

[charly90]

Like small punch in the groin

[Hammertown87]

whats an extra 30 days to make it right

[LeafRider]

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[AtownMtl]

Don’t bash aphria! That’s what happens when you rely on multiple partners, aphria has been busy locking down shoppers, expansion etc.. without aph tetra would not be where it is now. you 

[LeafRider]

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[AtownMtl]

Sharpen up ? When I mentioned that TBP should continue ACMPR process you told me to go join Andre LOL and this coming from a guy who thought aphria had 200000 patients and tried to brush it off as a typo ! And I should sharpen up ?? 

[LeafRider]

This post has been removed in accordance with Community Policy

[LeafRider]

This post has been removed in accordance with Community Policy

[AtownMtl]

you said this 1 week ago !! be honest leaf i can post it also !!! 

[AtownMtl]

i can post the oil DIN conversation also ? do you remember ? you said i didn't know what i was talking about when i mentionned they should get DIN for oil ! STOP being a SHEEP ! it's ok for people to have opinions.

[Bigballs1974]

 I will agree they should’ve had this done and put in place but at the same time have you ever built a business how come you’re so impatient this is a brand new industry maybe you need to take a little sit down .  Things take time and I don’t care honestly one month that’s not even really worth writing down any of these words .  Shame on you you get Deducted one demerit.  You

[Bigballs1974]

I’m being silly but yes if this baby goes to .60 I’m grabbing a ton :) 100% cause long I am Sam and it’s a good investment and for everything else in life there’s ‍‍‍

[JoeRoganBNN]

Well Tetra had promised before 2018, now its going to be at the earliest early 2018.  Another stagnant week ahead!! Ballz, i knew i should have sold a few shares on Friday.  Never ending how i havent made any money.  Been in it for 7 or 10 months now. Oh, well, whats another 8 or 9 months. 

[Bigballs1974]

Exactly disappointing I guess but making money buying and selling or just reposition and buy up more just another opportunity while there cheep.

[MichelC58]

a month is nothing ... I buy more if it drops Monday

[JoeRoganBNN]

News released on the weekend has less of an impact than posting it on Monday morning, I find. Still, not good news, hopefully people forget about it. Lol shyt happens meh

[new2mjstocks]

why is it such bad news?? its a minor max 30 day delay

[Shadd76]

This post has been removed in accordance with Community Policy

[LeafRider]

This post has been removed in accordance with Community Policy

[Chuck03]

The best thing about this, is that they are getting the inspections out of the way to guarantee consistency. This allows for faster approval, where Health Canada could say we need this, here is a DIN (especially when July 1st comes) in order to differentiate recreational and medinical marijuana. This is in comparison of having to wait to finish Phase 3 to then have an inspection, where if the

[Catalystking519]

We have been working hand in hand with Health Canada,  anyone else notice this? Do they always make these reccomendations?  I think it bodes very well for tetra moving forward every step of the process.  We all know the end game is a DIN# and if we can continue to have excellent communication with Health Canada this can happen faster than we all thought, jmo.

[TripleEm]

Kinda sounds like Health Canada is the ones that are lagging.  the Company has accepted the suggestion of Health Canada to change the order of its clinical trial application (CTA) review process. As such, the quality certification for the manufacturing of PPP001 will take place prior to the approval of its clinical trial protocol as Health Canada assesses its partner Aphria's operations