Motif Bio Share Discussion Threads

[h2owater] 15/4/2015 07:26

Market reaction positive, hopefully, but for how long?

[saud2237] 15/4/2015 07:24

TRANSFORMATIONAL NEW!!!! WILL GET TAKEN OUT SURELY

[rogen83] 15/4/2015 07:22

FDA approval, lift off

[mirabeau] 15/4/2015 07:05

Interesting

[saud2237] 14/4/2015 16:34

Just seen the director popping some champagne (through the keyhole) lol

[dosser2] 14/4/2015 15:51

In for a few. Worth a punt.

[granada7] 14/4/2015 15:48

Duxy, where u from, noticed the 786

[duxy786_3] 14/4/2015 15:48

Then you mean no. Your not in the meeting....your just a dirty perv! LOL ....
Only kidding.

How do you know the meeting has started? It could be anytime today when they discuss Motiv and RNS out tomorrow or Thursday!

[saud2237] 14/4/2015 15:33

yes I am observing through the keyhole

[duxy786_3] 14/4/2015 14:32

Saud, you in this meeting?

[saud2237] 14/4/2015 13:58

Meeting started

[saud2237] 14/4/2015 09:51

Do you feel that your IPO valuation fairly reflects the business and the stage that you are currently at?
Graham Lumsden - We believe it undervalues the company compared to its peers. By coming to AIM now, we have met our two immediate goals of closing the merger transaction with Nuprim, granting Motif exclusive worldwide rights to develop and commercialise iclaprim, and to raise sufficient funds to complete preparations to enter Phase III with iclaprim.

[saud2237] 14/4/2015 09:51

- At what stage are the other antibiotics that re-applied for approval and what are their estimated valuations?
Graham Lumsden - Paratek listed on Nasdaq in 2014, raising approximately US$100 million to develop a tetracycline antibiotic called omadacycline, whose Phase III studies are set to re-start in the first half of 2015. Paratek’s market cap increased to approximately US$574 million following the acquisition in January 2015 of Cubist by Merck & Co., Inc. for US$9.5 billion. Durata Therapeutics Inc. (NASDAQ:DRTX) was acquired by Actavis (NYSE: ACT) in October 2014 for US$675 million plus contingent value rights, following the approval for its first antibiotic in May 2014.
- What is the next step for Motif PLC and when can the market expect further news flow?
Graham Lumsden - A meeting with the FDA has been scheduled for 14 April 2015 to discuss the Phase III programme for iclaprim. We will update the market following the meeting.

[asturius101] 14/4/2015 08:41

Looking interesting

[duxy786] 14/4/2015 08:10

-- The Company is seeking to confirm in meetings with the FDA and EMA in the first half of 2015, that the clinical development plan for iclaprim meets regulatory guidelines and that two Phase III trials can be conducted. A Type C meeting is scheduled with the FDA for 14 April 2015.Ready, set......whoooosh.

[timbo003] 13/4/2015 08:56

>>>>Aughton

Yes, AMP has debt.

NAV for AMP in September was 2.4p, not sure what it would be now given that their MTFB stake can now be valued on quoted market cap for MTFB, need to look at that.

[1bond] 13/4/2015 08:50

Reneuron today files application for new drug phase 1. Market cap £63m. Other assets at phase 2, so a long way behind Icaprim.

[aughton 3] 13/4/2015 08:40

Amphion has debt as well

[timbo003] 13/4/2015 08:27

>>>>>1bond,

yes looks very cheap if you assume it will be successful in getting approval (it's a big if though).

Amphion (AMP) is probably the best way in

With a market cap of around £7M, it owns over 40% of MTFB

[1bond] 13/4/2015 08:01

This could be the cheapest AiM company with a phase 111 asset on the market. Market cap £18m.

[timbo003] 13/4/2015 06:26

I've just been taking another look at the info pack used to brief investors for Motif's IPO pitch, It gives a few details of what they are proposing for the clinical program (to discuss with FDA?), when they expect to achieve it and the market opportunity, see below:

[timbo003] 12/4/2015 17:48

The FDA meeting is scheduled for this Tuesday (April 14th), so I guess we may hear something on Wednesday April 15th about the outcome which would presumably be Motif's take on FDA's preliminary view.

I believe the procedure is that FDA will release official minutes of the meeting within 30 days (see slide 26)


It would be interesting to see the rejection letter from the previous unsuccessful application by Arpida in 2009, but I'm not sure that it's in the public domain, however I did find this:




The FDA's complete response letter, which the company disclosed on Monday, called for an additional clinical study - or studies - to demonstrate the drug's efficacy

"It's been stated in broad terms what they think should be done to achieve approval," Harry Welten, chief financial officer of Reinach, Switzerland-based Arpida, told BioWorld Today. It would cost between CHF20 million (US17.5 million) and CHF40 million to fund the necessary trials.


Things have obviously moved on since 2009 and I suspect it will be a case of seeking FDA advice on selecting the most appropriate controls and endpoints for the proposed study(s), I'm wondering if now they will also need to conduct a paediatric study in parallel, or whether they will get dispensation to run that after the completing the adult study(s) and NDA submission (assuming a successful outcome).

[cottoner] 12/4/2015 13:29

Snippet from Luke Johnson's article in today's Sunday Times

Giant drug makers are paying insane prices for biotech firms because they appear to have lost the ingenuity and confidence to discover new drugs themselves.

[cottoner] 12/4/2015 13:28

Snippet from Luke Johnson's article in today's Sunday Times

Giant drug makers are paying insane prices for biotech firms because they appear to have lost the ingenuity and confidence to discover new drugs themselves.