Motif Bio Share Discussion Threads

[alexios1201] 06/6/2019 07:40

"Even a short trial won't start until late this year and assuming successful a new NDA can be submitted, maybe, by the end of 2020 and FDA approval late 2021. Will need at least $25m to get there IMO."calamari posted on lse

[buywell2] 06/6/2019 07:32

I did say ... new clinical trials needed and they can cost many tens of $ millions dependent on numbers of people needed.

IMO the FDA will say a pretty large cohort to get more data on DILI

Cash raise coming within weeks if not days IMO

In my opinion the trials will cost so much they won't happen and monies raised will be used for something else

dyor

[bocase] 06/6/2019 07:30

The market already knew that funding was going to be required but at the leat statement says...

"The Company is evaluating options to determine the funding strategy that will be most favourable for shareholders and will provide an update to the market in due course."

[letmepass] 06/6/2019 07:26

Funding will be required.. No gas in the tank..

[rk23] 06/6/2019 07:18

I think short term this is not ideal, may see a drop back to 5p, long term - plenty to play for, could be a short rally in morning as the first point of uncertainty has been removed.

[global nomad] 06/6/2019 07:13

so now we know....clarity perhaps but need for 'diligent cash management' and fundraising likely to send share price down...so now its about selling or adding...

[rk23] 06/6/2019 07:08

Motif Bio Announces Path Forward for Iclaprim following Receipt of FDA Meeting MinutesConference call scheduled for Thursday, June 6, 2019 at 8:00 AM EDT/1:00 PM BST/2:00 PM CETMotif Bio plc (AIM/Nasdaq: MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, today announced that the Company has received the official minutes of the Type A meeting the Company held with the U.S. Food & Drug Administration (FDA or Agency) on May 3, 2019, to discuss the points raised in the Complete Response Letter (CRL) related to the New Drug Application (NDA) for iclaprim, for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The minutes indicate that an additional clinical trial will be required prior to granting marketing approval to address the Agency's continued concerns about potential liver toxicity. The Company has been encouraged by the FDA to put forth a proposal for a future study and to submit it for review. The Company plans to request a meeting with the Agency to discuss the design of the study, including the appropriate patient population to be evaluated.Dr. Graham Lumsden, Chief Executive Officer, said: "We now have confirmation of what will be required for a path forward for iclaprim. We intend to meet with the Agency to agree on the specific requirements of the trial, which will enable us to estimate its size and scope and, therefore, the costs and funding requirements. In parallel, we expect to continue our discussions with potential commercial partners and will determine the best options for funding the trial once we have clarity from the FDA.""We continue to believe that iclaprim has the potential to be an important new treatment option for hospitalised patients with ABSSSI and potentially also in patients with hospital-acquired bacterial pneumonia, including ventilator-associated bacterial pneumonia. In addition, we are exploring the use of iclaprim in other disease areas, including orphan indications such as Staphylococcus aureus lung infections in patients with cystic fibrosis and in ophthalmology, as evidenced by recently announced collaborative agreements. Completing the steps necessary to provide the additional trial data to respond to the Complete Response Letter is our top priority. We are also continuing our business development activities to position Motif Bio for long-term growth by building a robust development pipeline. In parallel with our focus on iclaprim, we continue to pursue a variety of attractive opportunities in the anti-infectives space, as well as in other key therapeutic areas."As of May 31, 2019, the Company had a cash balance of $2.3 million and $7.1 million of outstanding debt drawn from the Hercules Loan Facility. The Company believes the current cash position can support continued operations into September 2019 with diligent cash management. The Company will need to raise additional capital, which may be through equity financing and/or from non-dilutive sources. The Company is evaluating options to determine the funding strategy that will be most favourable for shareholders and will provide an update to the market in due course.Conference call scheduled

[telbap] 06/6/2019 06:57

The Silence is deafening

[rk23] 05/6/2019 16:44

Maybe not.......

[rk23] 05/6/2019 15:43

News about to break......

[small crow] 04/6/2019 20:58

No-one knows ...... but you knew that.

[philipc240] 04/6/2019 18:12

Is delay good or bad news? As a holder like to suggest good news with complimentary details on funding and path to approval without re-trials...

[telbap] 04/6/2019 10:47

Still waiting

[telbap] 03/6/2019 11:54

I believe it is now 30 days.

[rk23] 03/6/2019 08:19

Is today last day of the 30 days for FDA to provide minutes of meeting? Unless they ask for extension?

[telbap] 03/6/2019 08:15

Wow, they accepted the snouts out today the trough vote......impressive.

[small crow] 31/5/2019 19:53

Big buy that, after hours.

[rk23] 31/5/2019 11:41

Probable reducing position ahead of next rsn - as a buy under 9p see limited risk regardless of FDA outcome...

[ajseabright] 31/5/2019 11:22

Cheers guys

[small crow] 31/5/2019 11:15

Try reading it.

[ajseabright] 31/5/2019 11:12

RNS is that someone decreasing their stake??

[small crow] 31/5/2019 10:12

Be nicer to break 20...