Member Info for Ivyspivey

Yes timelines are pretty clear. Submission of NDA Q1/2018 and acceptance by FDA within 2 months and Approval de ision within 6 months. Allowing for Xmas period as you highlighted are virtually identical. Not sure if black box made any difference as standard precaution with Fluaquinalones

Hi Shellie. Getting a CRL is normally always bad news but its impact is determined by its content.The biggest increase in recent times is due to concerns over the manufacturing side of things and I know MTFB have been working very closely with the FDA over the CMC side and as they already had trial supplies of Iclaprim Approved this should not be an issue. If there was a question over insufficient data then the delay would be the length of time to overcome this hurdle and this would likely be several moths. Again the extensive safety and efficacy data for Iclaprim not only in Revive 1 and 2 is very much in its favour.The fact the FDA were very co operative in agreeing the protocols and that.Covance were used us all very positive. The fact that renal issues were virtually absent from the phase 3 results and no Iclaprim patients died and some of the trial abnormalities were purely as a result of random allocation of patients is fine imo The desperate need for new ABs all vastly encourages me that there will be an extremely low risk of a CRL but that is why the submission of the NDA takes a long time to get it right. If there are any concerns the FDA can always approve but just put in additional monitoring etc it I don't think this will be necessary.

Very high chance of Approval given positive p3 trials If you consider the FDA Approved Baxdela with Black Box then Iclaprim should be very srtraight forward http://melinta.com/melinta-therapeutics-announces-u-s-fda-approval-baxdela-delafloxacin-acute-bacterial-skin-skin-structure-infections-absssi/

Yes once the NDA is submitted and accepted then MTFB will really ramp up Pre US commercialisation such as recruiting MILs etc. Knowvtgey are working very closely with FDA but to me if no CRL (Complete Response Letter) then that Approval is a given imo

Yes once the NDA is submitted and accepted then MTFB will really ramp up Pre US commercialisation such as recruiting MILs etc. Knowvtgey are working very closely with FDA but to me if no CRL (Complete Response Letter) then that Approval is a given imo

Agree mate but at some point they will run out of ammo. Either on news or sentiment this will rise quickly and most LTHs will wait until much higher before considering selling so rIse should be sustained. Personally think it will rise as NDA Application gets close.They May even spring a surprise in February.

Ha ha indeed But again as soon as you get a rise the ATs kick in by the DMAs to bring it down again. So why.? Any true seller may sell into a rise but not by a series of ATs designed purely to keep this range bound.

Hardly desperation imo Just letting the market know and follows JPM so may be timely but yes not major news

Motif Bio to participate in panel discussion at upcoming Cantor Antibiotics Summit Motif Bio plc (AIM/NASDAQ: MTFB), a clinical stage biopharmaceutical company specialising in developing novel antibiotics, announced today that the Company will participate in the following event: Cantor Antibiotics Summit January 17, 2018 Omni Berkshire Hotel New York, NY USA Graham Lumsden, Chief Executive Officer, will participate in a panel discussion, "Catalysts to Look for in 2018." The Cantor Antibiotics Summit will bring together leading antibiotic companies to discuss: what will drive the uptake of these new products, novel ways to treat infections and important catalysts to look forward to in 2018. The Summit will consist of various panels, in addition to one-on-one and small group meetings.

At 55.8% and no directors have tendered any

I have never been able to explain it but as Shellie says it is the very rapid ATs that do walk this down every time there is arise. So someone is trying to keep it rangebound.

Yes I am a fan of the old Bond movies. Even thought about dying our Persian Cat with the Peroxide to look like Blofelds lol

Not mine mate I don’t do TA put Got it from ma5k who posted a load on M board. He is happy to allow posting. Thought you would be watching latest Bond movie

Courtesy of ma5k. http://www.tellas.co.uk/Charts/MTFB_17-12-29.jpg

CMC=Chemistry,Manufacturing & Controls NDA=New Drug Application DMF=Drug Master File

Know that everything is on track for NDA submission including CMC requirements so presume if anything under these required a DMF then it would be submitted. Also Beginning on May 5, 2018, new DMFs, as well as all documents submitted to existing DMFs, must be submitted using the Electronic Common Technical Document (eCTD). DMF submissions that are not submitted in eCTD format after this date will be rejected so would imagine they will include everything necessary in the NDA which we know will cover hundreds of 1000s of pages. MTFB are very circumspect in not being assumptive of any future FDA decisions but are in regular communication with them during this process and have found them to be extremely helpful,supportive and co operative in terms of submitting Iclaprim for Approval.

Not heard anything and expect some general communication post JPM in next 2 weeks maybe giving update on NDA submission and report back from JPM. Now that the AMP share situation due mid January has been resolved and the SP seems to be acting “normally” then the pathway is clear. Main priority at moment is NDA submission and think they will try hard to get done before Superbugs and Superdrug’s on 12th March and they like to get news out early as we saw with Phase 3 results. HNY All

HNY to all and finally looks like we can say 2018 will be our year here.

Day 2 1.40 DH ya Talking about Iclaprim. Follows Mair Powell lead Clinical investigator at EHRA https://www.smi-online.co.uk/pharmaceuticals/uk/superbugs-superdrugs

TyraTech Inc. (AIM: TYR, and TYRU), the life sciences company focused on nature-derived insect and parasite control products, announces that at the Special Meeting which was held at 3.00 p.m. (EST) on 27 December 2017 at the Company's principal offices, 5151 McCrimmon Parkway, Suite 275, Morrisville NC 27560 USA, the resolution was duly passed. As a result, the Company is pleased to announce that the sale of its human lice products brand Vamousse® to Alliance Pharma PLC (AIM: APH) ("Alliance") for an initial cash consideration of $13 million with further payments of up to $4.5 million based on the achievement of agreed sales performance targets for Vamousse® in 2019 and 2020, will now proceed with immediate effect. TyraTech was advised by Oriole Advisors on the sale. Following the sale, TyraTech intends to focus on the opportunities within the estimated $6 billion addressable animal health market for control of insects and parasites, a sector in which it already has considerable management experience and new products in commercial stages.