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Accelerated Approval for RECCE® 327, page-45

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Tiredandhungry

274 Posts.

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16/05/18

20:23

Post #: 33145348
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Originally posted by baldymyer ↑

Hi all.
A couple thoughts from me. And thanks for everyones input and conversation, seems like a good healthy bunch of investors.
Tieredandhungry mentioned this announcement is stuff we already know, I don't think this is 100% accurate. My understanding from previous March 8th announcement stated "open communications with the US regulator as the company seeks to set the regulatory pathway in a clear and expedient direction" whereas my take on todays announcement is that QIDP (GAIN) has now labelled RECCE® 327 for Fast Track it announcement states "labelling RECCE® 327 for Fast Track designation, plus 10 years of market exclusivity post approval." If I've read correctly then RCE have been told they will now be fast tracked, small difference in wording but major difference in what it means.

I suspect the minuets of their meetings will shed some more light on things, I'm thinking that another announcement is likely imminent stating RECCE® 327 has been labelled for fast track (not "labelling" as this indicates in the process of being labeled).

Chatterbox I respectfully hope your wrong mate. I understand what your saying but I think if this is being fast tracked it's because there is a serious need for it now. Also I agree with your comment about over subscribing this new drug and perhaps they will recommend for it to be used only as a last resort after everything else has failed. However I think that doctors all around the globe will be prescribing this like bubble gum as they have done with all the other antibiotics on the market today. Lets face it I think it is generally agreed that the world is in this superbug crisis today because doctors over and incorrectly prescribe antibiotics, I for one don't think for a minuet that they have learnt a lesson they will take the easy way out every time.

I'm hoping that we may get an indication in the minuets from the meeting(s) about the length of time for the fast track process.

Lets also remember on 01/02/2016 RCE closed out at 44c this is a one time ago, now they are at FAST TRACK FDA status. If at 40c then I think as Chebbbit stated previously in prediction $10 end of this year is possible.

Good luck all, and please I only reference posts from others in a productive way (I hope I have anyway).
Regards,
Baldy

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Hey mate, I was referring to the ann on 16/11/17

https://hotcopper.com.au/documentdownload?id=uOMxKKzFkiWRTLKhOROKAxjvTDYC5Q67wBSZsvR8ke92GA==

“Through the grant of QIDP designation, RECCE® 327 is labeled for Fast Track designation which is designed to speed the FDA’s review process”

And todays ann says:

“QIDP designation is part of the US Generating Antibiotic Incentives Now (GAIN) Act, labelling RECCE® 327 for Fast Track designation“

Looks like the same thing to me?

RCE Price at posting: 17.0¢ Sentiment: Buy Disclosure: Held
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Accelerated Approval for RECCE® 327, page-45

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Accelerated Approval for RECCE® 327, page-45

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