Motif Bio Share Discussion Threads

[drmaccers] 03/2/2019 08:29

I think that sounds fair.On my chart I've a 74p initial target

[toolsmoker] 03/2/2019 08:21

I see mtfb as trading between 70p and 100p after fda approval .been a dull few years but surely now is the time or never

[drmaccers] 03/2/2019 08:10

Here come the partially researched shifters/derampers LolParatek got to £600mill+ before some difficulties and are currently twice MTFB Mcap.

[mirabeau] 03/2/2019 07:14

b1467 - Yes, you make a very pertinent and I would say valuable point that many would be wise to take note of

FDA approval is a valuable step in a pharma company's development but of far more importance is the company's commercialisation strategy. The company must be able to promote and sell the drug to the customer and do it at a good margin

Investors mustn't think that FDA approval is the conduit to untold riches. It's merely a start in the process of turning the company into a commercial operation (generating sales, generating profit and most importantly of all, generating free cashflow)

I believe MTFB will do well but it will take time to break down the monopoly of Vanco. so commercialisation may take some time but I believe the company will in time achieve their aims

[best1467] 03/2/2019 06:58

Just a word of caution Paratek in the same sector on the Nasdaq had two approvals in the same area recently and the shares have not performed well they actually have dropped from a 12month high of around $20 dollars all the way to $4 they have just started to recover.

[catch007] 01/2/2019 17:31

Nice spike today in share price as we get closer to the FDA outcome.....fingers crossed!

[bountyhunter] 30/1/2019 19:42

There's a documentary on BBC1 at 20:00 "The Truth about Antibiotics"

[dstorey1] 24/1/2019 18:21

Nothing is ever certain, apart from death:(, but these are a screaming buy given likelihood of FDA approval 13/02...not to mention requirement for new novel ABs and scope for big pharma takeover.

[bountyhunter] 24/1/2019 09:25

"Drugs companies are paid for the amount of antibiotics they sell.

The government says this has led to a "market failure" where companies are incentivised to sell existing antibiotics, rather than innovate and develop new treatments for infections where they are most needed.

By changing to a model where companies are paid based on how valuable the medicines are to the NHS, the government hopes companies will start to invest in the development of new, high-priority drugs."

[adorling] 24/1/2019 08:55

Plenty of BBC news exposure on AB resistance and the urgent need to develop and approve new AB’s

[alan@bj] 23/1/2019 14:56

Previous (recent) posts re FDA shown below. Only the first one was mine.

While the FDA is continuing to carry out reviews funded by fiscal year (FY) 2018 Prescription Drug User Fee Act user fees, including the review and approval of new drugs and biologics funded by carryover user fee balances, the agency is not accepting FY 2019 user fees until funding appropriations have been authorized, i.e., the political impasse has been resolved. Consequently, the FDA has suspended reviews of existing Investigational New Drug (IND) and Biologics License Application (BLA) applications not covered by user fees, and is not reviewing applications for new drugs and biologics submitted during the shutdown period, except for emergency INDs and BLAs.

hxxps://www.statnews.com/2019/01/14/shutdown-impact-on-drug-approvals/
As you can see this will NOT affect the Approval decision for Iclaprim only new NDA submissions.

I contacted Motif Bio directly to ask whether they have any info on likelihood of the shutdown affecting the PDUFA date and got this positive response from Laurie Doyle today:
"Thank you for your e-mail. The FDA currently continues to review the NDA for iclaprim, despite the government shutdown." Feeling reassured.'

[waterloo01] 23/1/2019 14:41

Potential FDA delays because of shutdown is the reason IMO

[small crow] 23/1/2019 14:39

I'm pleased for you. Keep up the AllBran.

[mike1608] 23/1/2019 14:22

Big movement today

[barriew] 19/1/2019 10:21

Nothing new but recommendation on Interactive Investor.

Motif Bio (MTFB)

39.53p

Motif Bio (LSE:MTFB) is developing a new antibiotic called iclaprim. Resistance to existing antibiotics means that it is imperative that new and effective antibiotics are brought onto the market.

Iclaprim was originally discovered by Hoffman-La Roche and Motif addressed the reasons it failed to gain FDA approval in 2009. Two phase III trials have been completed in the US. The addressable global market for iclaprim could be worth $2.8 billion.

The FDA has accepted the filing of the company's new drug application for iclaprim, relating to the treatment of acute bacterial skin and skin structure infections (ABSSSI). It has been granted priority review with a potential approval date in the first quarter of 2019.

Source: TradingView (*) Past performance is not a guide to future performance

Commercialisation plans have commenced. It is likely that the US hospital market will be targeted via a contract sales organisation, while in Europe a partner will be sought to help to finance approvals in the region.

Motif had $19.8 million of cash at the end of June 2018 and the cash outflows have reduced. More cash is likely to be required in order to launch the product.

Motif Bio's multi-billion-dollar best-seller
The share price has bounced back in the past few weeks and is not far from its 12-month high – but there should be more to come. The share price is nearly double the 20p a share AIM placing price just short of four years ago. Just over two years ago there was a fundraising at 28p a share as part of the Nasdaq flotation. Barely more than one month ago the share price was below that level.

If obtained, FDA approval will increase investor interest on Nasdaq, in particular, and could herald a further share price boost.

[bermudashorts] 18/1/2019 14:59

Reassuring post this afternoon on lse from Safari:-

'Hi All
I've been holding since last May, think this company have a strong future ahead.
I contacted Motif Bio directly to ask whether they have any info on likelihood of the shutdown affecting the pdufa date and got this positive response from Laurie Doyle today:
"Thank you for your e-mail. The FDA currently continues to review the NDA for iclaprim, despite the government shutdown." Feeling reassured.'

[metis20] 18/1/2019 10:56

Approval can come before the PUDFA date

"Another place to look is at PDUFA dates, and in doing so there is perhaps reason for cheer. During January and February there were 15 PDUFA dates, 3 of which resulted in Complete Response Letters and 12 of which were approvals, some of which not only occurred early, but very early. At least three of these were approved in December 2017, two months before the PDUFA date. Of the approvals during the first two months, 9 of them were NDAs and 6 were sNDAs."

[ianb5004] 16/1/2019 23:32

hxxp://ir.motifbio.com/phoenix.zhtml?c=254416&p=irol-newsArticle&ID=2363525

Target date is 13th feb. Pretty much set in stone

[bountyhunter] 16/1/2019 22:04

Thanks for the clarification, even better, had to read that twice it's been a long day!

[markymark33] 16/1/2019 21:45

FDA decision on Iclaprim is expected by 13th Feb, not on 13th Feb. So anytime from tomorrow until 13th Feb