Motif Bio Share Discussion Threads

[gclark] 15/6/2018 07:25

I can't remember what has been said on the timing of the submission to the EMA? clearly all resources should be put into that without delay.

[gersemi] 15/6/2018 05:23

C007

I do have a few here though not many, yet.

I believe the time to really pile in is not yet upon us so imho now is a good time to slowly accumulate bits and bobs -

Is FDA approval a fait accompli? We shall see but I believe approval is far more likely than the worst case scenario, which is the FDA refusing to approve.

The next step is taking on Vancowhatsitsname and persuading the medical world to start buying Iclaprim - surely there's enough room for both?

Peel Hunt does have a 102p price target on MTFB - some stuff PH in the link below posted on another site



-

As with most of stocks I own, patience is the key -

[return_of_the_apeman] 15/6/2018 02:10

Exactly gclark, imo just a case of waiting now and buying any dips

[gclark] 14/6/2018 16:20

two different situations though
with IMM it was all about the outcome of a clinical trial where the results were unknown, although the Chairman kept on implying the results were going to be positive, in my view unprofessionally
with Motif, the results of the two large trials are known, meet the primary end-points, show better results in renal patients than other medications
and the outstanding issue is whether the FDA will give it a licence, which for me is almost certain for the reasons stated before

[catch007] 14/6/2018 16:05

gersemi: worth another punt fella? if it gets approval could be another OXB if not its another IMM …..I have a good feeling on this one though.

[gclark] 14/6/2018 12:03

Thinking of timescale from now …
Iclaprim has already been to the FDA and was refused on the basis it did not show non-inferiority to vancomycin at 95% CI. That was the whole point of the two Phase III trials, so that has now been achieved. On that basis the only key thing they really need to consider is whether the data shows this, and to me the data is pretty robust.
And then there is the benefit in renal patients with ABSSSI, whether it can be classified as an unmet need, perhaps, as it doesn't harm the kidney to the extent vancomycin does, and it is a new antibiotic with an under-used mode of action, I think it will be considerably shorter than the maximum of 8 months from now

AIMV

[gclark] 14/6/2018 09:57

as you say, there wouldn't be any point in a rolling submission if it didn't speed up the process

[blueblood] 14/6/2018 09:06

Upto 3 months to confirm acceptance then maximum 6 months for decision. With rolling submission would hope to hear submission has been accepted by end July.

[return_of_the_apeman] 14/6/2018 09:04

Adding more, was getting a bit nervous about the delay, thankfully mms have not marked this up more at the opening bell :-)

[gclark] 14/6/2018 08:38

This is good news
My concern had been that the company had said they 'expected' it to be submitted in Q2, which wasn't a sufficient statement for me to ensure that everyone was committed to Q2
As I have said, I think Iclaprim will be very successful and consequently a company changer for Motif
The company met its target (a couple of weeks early)
Now things will move forward

[escapetohome] 14/6/2018 07:52

BBB LLL UUU EEE FFF III NNN III SSS HHH !!!

[timbo003] 14/6/2018 07:37

It's been a long wait. Should be a Blue day today

[gersemi] 14/6/2018 07:19

'Upon acceptance of the filing of the NDA by the FDA, iclaprim will receive Priority Review, a review period of six months'

I wonder if that period is up to six months or within six months? Could they receive approval within the 6 month review period?

[t-trader] 14/6/2018 07:07

Finally, completion of NDA submission. Another key milestone reached for MOTIF.

[unionhall] 08/6/2018 21:50

From poster on LSE......




Webcast now on website but you have to register
GL said NDA complete so expect RNS confirming submission very soon

hxxp://wsw.com/webcast/jeff113/mtfb/

[razmo1] 08/6/2018 17:36

No just transferred directly to Sandgrove I assume

[librayang0925] 08/6/2018 17:14

Bank of America dumped all their shares?

[blueblood] 07/6/2018 14:35

Be dead at the rate they are going at...where is the NDA submission completed RNS?

[speeding granny] 07/6/2018 13:37

are we going to speed up towards 100p?

[return_of_the_apeman] 05/6/2018 13:59

Hopefully they will get a few lsrge investors on board too

"The Company also expects to participate in one-on-one meetings during the event.

[return_of_the_apeman] 05/6/2018 13:54

Wondering if the NDA submission will be in the morning of the 8th before this

Jefferies Global Healthcare Conference

June 5-8, 2018

New York, NY USA

Graham Lumsden, Chief Executive Officer, will give a company presentation on June 8(th) at 10:30 AM ET. The presentation will be webcast, available live and as a replay in the Investors section of the Company's website.

Either way, am expecting it may get a mention :-)

[t-trader] 03/6/2018 11:05

Personally, I would sooner they take their time and ensure the NDA is completed accurately and each section checked thoroughly prior to being submitted. Yes, it is taking a while to complete and although frustrating for shareholders, any errors in this document would be far more costly if they had to resubmit due to some small technical error which had been overlooked.

[gclark] 02/6/2018 09:55

Sorry to bang on about this, but this is not impressive. You can download the contents of an NDA from the internet. You can see that there are sections that need completing, and each section might take a few weeks to put together. But you don't need to do it consecutively section by section, each section uses information already available to the company, it doesn't rely on information in the previous section.
If you write a book, you need to write chapter 1 before chapter 2 and so on. Not in a document like this.
If each section takes a few weeks/a month or so, have them all being done at the same time, and then checking, editing, making sure the document flows and is consistent, then you can complete it in 2-3 months.
The fact that they have been talking about a rolling submission implies to me that the same people are working on sections one after the other.
It has not been in the interests of shareholders to have managed the submission in this way.

Just to finish on a positive! I think the clinical evidence for Iclaprim is very impressive which is why I am invested. And we have been promised the full NDA submission by the end of this month. It is needed as early as possible. If the EMA submission follows, please get it done quickly and be dubious of consultants wanting high fees and to delay submission.

[gclark] 31/5/2018 10:17

There really is no excuse as to why this is taking so long to complete a document, unless there is another clinical trial going on, which I cant believe there is as we haven't been told. This is time critical, you can't let the consultants/CROs drag this out. It is starting to imply poor person management and/or contract management, and I did have a positive view on Motif's management.
In the meantime, shareholders suffer.

[blueblood] 25/5/2018 16:18

Need to complete Submission to FDA. It was nearly com0lete 2 months ago Mr Lumsden!