Motif Bio Share Discussion Threads

[lionheart69uk1] 04/1/2019 20:34

I bow to the superior knowledge of more earnest investors, who seem to rate the chances of FDA approval more highly than I was expecting. Have an open mind is my motto. I won't be prioritising this stock however.

[rabito79] 04/1/2019 17:40

Are you not worried about this plummeting to oblivion anymore then?

[lionheart69uk1] 04/1/2019 14:36

Waiting for the market to drop a little as 31p is a tad too expensive for my taste.

[return_of_the_apeman] 04/1/2019 12:23

Fwiw, I rate the outcome of approval at over 95%. But if we use a lower figure of 85%, if I offered anyone a dice and said I will give them even money everytime they roll anything other than a 1; if the bet was limited to 10% of your portfolio how many times would you roll it

Opportunities like this are easy money imo providing you can identify enough of them and are sensible with your stake

[return_of_the_apeman] 04/1/2019 12:12

Think I have under estimated the potential market in a previous post . If Iclaprim is cheaper than Vancomycin as indicates then the market in the US alone is $8billion per annum by my estimates

[small crow] 03/1/2019 16:55

Autos back.

[ianb5004] 03/1/2019 15:11

Copied a post from lse which is common knowledge to those who have researched MTFB and
Iclaprim. I do wonder about the motives of those who still raise this as a concern as it really shouldnt be. Nothing is guaranteed of course but the previous submission is not an issue.


in summary.
As for your specific point you are right that Iclaprim along with 3 other ABs (Antibiotics) failed to get through the Approval process on 2007/8.This was mainly due to FDA approving an AB called Tekek which got a Approval then had issues so they took a very hard line on Approving all ABs at the time.
Firstly there has been a sea change in attitude of Approvals in ABs due to desperate need for new ABs causing AMR(Anti Microbial Resistance) and lack of supply of new ABs.
The other 3 drugs originally refused have all now been Approved.
Also MTFB have made lots of critical changes to phase 3 trial protocols which have led to a better chance of Approval from the original Assust trials.
They consulted with FDA and agreed a Non Inferiority (NI) of 10% rather than the previous 12.5% and the change if comparator drug from Linexolid to Vancomycin.Both these changes were wanted by the FDA but Arpida the original holder of Iclaprim decided on different parameters.
They also made changes to a fixed dose of 80mg I/v rather than a variable dose rate.This was suggested by FDA to overcome some of safety issues highlighted in previous trial without effecting efficacyl;
They also increased trial numbers and covered more US sites in Revive trials
Also used Covance a top CRO
These changes have passed both Revive 1 and 2 and the NDA submission has been accepted without the need fir an Ad Comm.Hope this helps and welcome to the board

[barriew] 31/12/2018 13:04

As you say it should be in the bag, so you take your chance.
Buy now and we should get a decent rise up to the FDA decision, the latest date for this is the 13 th February. So could even be late January.
If you buy later after the FDA decision the price will certainly be a lot higher but your guaranteed not to loose if the decision was negative.

My preferred choice is buy now ( been here over 2 years) and take some profits before FDA decision is known.
Good luck all and for 2019.

[gersemi] 31/12/2018 10:16

m1608

My advice. Wait until FDA approval and then take a position. I personally believe FDA approval will be given for Iclaprim but there's always a chance it may be refused. If it is refused you're screwed. If approval is awarded then you'll be paying 50p+, easy

You pays your money and you take's the chance

ps - a price is what a price is - it is never cheap nor expensive (such a valuation relates to the company value afforded to it by investors. At present Motif has zero revenues so conventional valuation parameters do not apply)...what we have at present is a binary bet on FDA approval

Just be careful - that's all I'm saying

[mike1608] 31/12/2018 10:08

Is the current price still cheap to buy?

[timbo003] 31/12/2018 08:56

Given that approximately 80% of applications receive approval from FDA, I think it is reasonable to state that approval for Iclaprim is "expected"

[metis20] 30/12/2018 17:17

18 08 16



Motif Bio chief executive officer Graham Lumsden said: “The NDA acceptance by the FDA is an important milestone for Motif Bio and reflects the dedication and commitment of our team who have worked tirelessly to accomplish this.

“We believe that, if approved, iclaprim could be an important new treatment option for patients with serious skin infections. We look forward to working closely with the FDA as we move through the review process with the goal of bringing iclaprim to patients as quickly as possible.”

From today's Midas article -

Motif Bio is already well down the track. Trials have been completed and the US regulator, the FDA, is expected to approve iclaprim in February.



Interesting to know quite who is expecting approval of iclaprim. Presumably, following the success of the two phase 3 REVIVE studies, the MOTIF team are expecting approval.

[metis20] 30/12/2018 16:50

While Arpida was developing iclaprim, the FDA was re-evaluating the requirement for the non-inferiority margin to support approval of new antibiotics. The accepted non-inferiority margin when the ASSIST clinical trials initiated was -12.5%. However, in 2008 the FDA decided that compounds for the treatment of skin and skin structure infections required a non-inferiority margin of -10% instead of -12.5%.

When Arpida conducted the data analysis from the ASSIST trials the agreed upon non-inferiority margin was -12.5%, thus the company believed that the two trials each had positive outcomes.

Following submission of the NDA, the FDA “moved the goalposts” and evaluated the data for iclaprim using a non-inferiority margin of -10%, which was consistent with the revised guidelines.

The ASSIST-1 trial did not meet the -10% non-inferiority margin, and thus Arpida received a complete response letter (CRL) from the FDA. The FDA did not indicate that there were any concerns related to the way Arpida conducted the Phase 3 trials, however the agency did request that additional studies be conducted to demonstrate the effectiveness of iclaprim, which could include non-inferiority studies comparing iclaprim to an approved comparator.

Had Arpida been aware of the -10% non-inferiority margin requirement, the ASSIST trials likely would have been designed to include more patients in order to increase the statistical power.

Above is from

[metis20] 30/12/2018 16:49

Other Antibiotics With Similar Regulatory Pathway as Iclaprim

Iclaprim was not the only antibiotic to fall victim to the FDA altering the guidelines for non-inferiority testing in 2008. The FDA rejected oritavancin and dalbavancin each at approximately the same time as iclaprim based on clinical data that did not meet the 10% non-inferiority cutoff. However, both oritavancin and dalbavancin were studied in additional Phase 3 clinical trials (employing the same design as the REVIVE trials with vancomycin as the comparator) and each was approved for the treatment of ABSSSI in 2014. While some investors may be nervous about a compound that was previously rejected by the FDA, the fact that other antibiotics that were not approved for a similar reason as iclaprim have now gone on to be approved, should give investors confidence that Motif is
following the correct regulatory pathway for iclaprim.

Above is from

[gersemi] 30/12/2018 10:51

'Trials have been completed and the US regulator, the FDA, is expected to approve Iclaprim in February.'.....

How can anyone be certain of this? As Lumsden been given the nod by the FDA and then he's spoken to the now seditious Mail to pass on this snippet? It's a pretty bold claim to make

I saw activity on Friday and did think it'd be tipped by some rag or other...the Mail always engenders a decent rise first thing so don't buy first thing as you'll be buying expensive from the pre-tip sellers

The market, including myself, is eagerly awaiting the FDA decision

[lionheart69uk1] 30/12/2018 10:41

Despite obvious ramping by Daily Mail, you should be mindful that failure to gain FDA approval in February will see the share price plummet into oblivion. The same drug has already been rejected by the FDA when owned by another company, which bought it from Roche, not exactly a firm known for selling successful drugs rather than keeping them. Is the risk worth taking?

[tilly99] 30/12/2018 01:06

https://twitter.com/wynningtrader/status/1079161301014855680?s=12

[return_of_the_apeman] 28/12/2018 16:24

Think the broker target is 95p fwiw

[small crow] 28/12/2018 15:24

My guess - 80p.

[dstorey1] 28/12/2018 14:36

At what price will company be acquired post 13 Feb announcement?

[small crow] 28/12/2018 14:21

Looking good on decent volume.

[return_of_the_apeman] 27/12/2018 21:44

By my maths this is a potential of $1billion+ that could roll in every year from just the US alone




Based on an overall 9.2% rate of V-A AKI among patients with ABSSSI, iclaprim’s neutral acquisition price threshold was $1,210.26 per regimen ($172.89 per day) compared with vancomycin, according to the study. V-A AKI risks ranged from 9.2% to 16.7% across various subpopulations, the researchers said, and the upper end of the daily acquisition cost of iclaprim that still provided cost-savings varied between $150 and $300 a day.

[bowles22] 19/12/2018 17:53

Released yesterday by peel Hunt

Peel Hunt picks 'doublers' for the next 2-3 years

Clinical stage biopharmaceutical company Motif Bio could see its share price surge early next year, argued Peel Hunt, with the US Food and Drug Administration due to give possible approval to Motif's antibiotic iclaprim on 13 February. Currently trading at 26p, Peel Hunt is targeting a price of 95p.

hxxps://www.hl.co.uk/shares/share-research/share-tips/stockbroker-tips/peel-hunt-picks-doublers-for-the-next-2-3-years