Member Info for rebarm

Afternoon Ivy,

I've been back through material covering the FDA's level of involvement in the trial design for Revive 1 & 2 and would suggest it was not typical. At risk of being accused of ramping and/or in receipt of a large helping of egg in face in Q1 next year, I am now convinced that the FDA has a vested interest in the approval of Iclaprim. This probably driven by the lack of and need for narrow spectrum ABs and the resistance to and peripheral damage caused by the over use of broad spectrum ABs such as vancomycin (excellent article you posted last week, "Trends In US Antibiotic Use'). Assuming NDA acceptance later this month, then the next 6 should be interesting!

US patent extension announcement is perfect as it boosts MTFB's commercial negotiations which must be ongoing given acceptance/approval timescales. I've listened to the StockTube interview a couple of times and imo it contains an absolute gem! GL, as always calm, measured and informative, mentioned that it was on the FDA's recommendation that Iclaprim P3 trials used a fixed dose of 80ml regardless of patient's weight rather than the typical weight based dosage, their belief being that patients with low weight were not receiving sufficient medication. I research thoroughly before investing and continuously thereafter and was well aware of the FDA's active involvement in MTFB's trial design but had completely missed that the fixed dose was their recommendation. GL was very clear about it in the interview and I would recommend listening. The US patent covers not just Iclaprim but its dosage. That dosage has now been shown to be optimal for both safety and efficacy. Any competitor would therefore have to trial with a different dosage which, from the outset, would be sub-optimal. Why would any company waste significant funds and time running a lengthy trial using a dosage that was sub-optimal assuming the FDA agreed to it? My reading of this patent is that any competition has been effectively marginalised until 2037. Not a bad negotiating card!

I receive the US biotech web publication FierceBiotech and this webinar is in today's issue. Given our expectation that there will be a communication this month regarding MTFB's NDA, I thought there might be interest in gathering some more information on the process (it's not until 14th Aug so we may hear from MTFB before then!)

I have been in touch with the organisers as the registration form looks as though the event is directed at companies in the midst of prepping for an NDA. The response was, 'The webinar is open to anyone interested in attending the event. Please fill out the form as best you can to register for the webinar.' ET is 5 hours behind UK.

https://pages.questexweb.com/Rho-Registration-081418.html?source=spons

Use or ignore as you see fit!!

Not a major poster but wanted to add my thanks for your excellent contributions on this and other platforms. Always balanced and well thought through. Been a holder for a number of years and great to see the jigsaw develop and take shape. Exciting times ahead for all investors and most importantly those that can benefit from Opti's research

I like this board! No clamorous ramping/deramping by illiterate, aggressive punters with no interest in debate and no/limited knowledge of the science being developed. Instead pragmatic, objective and informed views.....in the main!!

Yesterday's posts a classic example with a very valid question from kelsbells and a balanced ivy response. To add to that and without wanting to give the impression of ramping, I would suggest that the role of the FDA following MTFB's acquisition of Iclaprim could, emphasise could, be instrumental in assisting NDA progress.

The FDA advised MTFB on the trial design which has been followed diligently. They granted fast track status and they also supported a rolling NDA submission. Their involvement surely indicates close engagement with MTFB throughout? Add to that the desperate need for new ABs, a situation that has been exacerbated recently by several development cancellations and the FDA must be under some pressure to find and approve new ABs?

Doesn't guarantee success either at the NDA stage or beyond but certainly helps with this investor's confidence.

Joining other LTHs who have dropped in over the last couple of days with calming, factual posts with a few observations following recent comments:

- MTFB typical small biotech still progressing through approval and dependent on news for sp stimulation. Whilst there is undoubtedly behind the scenes activity about which we can only guess/speculate, the sp is trading as I would expect.
- as has been pointed out, next news will be within 2 or 3 weeks with NDA acceptance from the FDA. Doubt if it will have a material effect on sp as NDA acceptance is already assumed by the market
- approval approximately 6 months after acceptance which will trigger conclusion of commercialisation.
- posts last week suggested that not having a deal agreed already is a sign of lack of interest in Iclaprim or weakness on the part of MTFB. Fundamentally disagree quite simply because it pays to negotiate from a position of strength. You can't get much stronger than FDA approval
- again referring to recent posts referencing big pharmas dropping interest in ABs implying that there is no longer a development interest and, as a consequence, MTFB may only see limited commercial demand. Comparing MTFB with Novartis, for example, is not even comparing apples and pears, more like apples and turnips! A company like Novartis may have an enormous R&D budget but it is still a finite pot and harsh business decisions need to be made around how best to invest that budget. It's a simple case of risk and reward. MTFB may only have one shot in the short term but there is a substantial and, unfortunately, growing demand for new ABs. Assuming approval they will do ok
- bear in mind that the primary reason for Arpida's (previous owner of Iclaprim) P3 failures and subsequent bankruptcy was because they didn't listen to advice from the FDA on how best to design the trials. Naive, stupid, short of cash not sure and don't care but note that MTFB worked with the FDA on trial design which was clearly successful and have been fast tracked because of the pressure for new ABs (Ivy, if you read this would appreciate your comments on this section as you are much better informed and I want to make sure I'm factually correct)
- finally any doubts remaining about MTFB then I would urge genuine holders to take the opportunity of meeting GL when he is next in the UK giving investor presentations. A class act compared with many of the cowboys masquerading as CEOs of many other AIM biotechs. I've met him on a number of occasions over the last couple of years and for what it's worth I rate him very highly and one of the major reasons why I have a substantial holding in the company.

Goes without saying that all the above is my opinion!!!

Time to go back to worrying about other AIM investments!!

Ivy, no not me. I was the one who started the questioning. I believe you were talking to GL at length after the formalities had finished while I was talking to JW. I then came across and interrupted your conversation to say goodbye to GL. Should have introduced myself at the time but will do so at the next MTFB meeting that we both attend. Appreciate the additional info from your GL conversation. Good to see that the BoD are very much in synch or have a well rehearsed party line!! Patience certainly a virtue with this one but whilst progress seems slow it is in the right direction and following a clearly defined and well understood path. I do like the pendulum analogy that both GL and JW are using. As long as markets don't get seriously spooked in the interim, there is no reason imo to doubt that MTFB's timing is spot on for securing an excellent commercialisation deal, whatever shape, once Iclaprim approved.

Catching up on posts re yesterday's AGM which I also attended. Firstly, many thanks Ivy for the detail on what was covered. Fully endorse everything you say. Couple of additional points from me: - acceptance of NDA filing by FDA takes 60 days after which, assuming positive, the 6 month clock for approval starts ticking. Based on that, acceptance should be through by mid August and approval/rejection from FDA mid Feb 19 - multiple options being investigated for commercialisation and no pressure on them to make a decision. A more favourable decision can be made later during the FDA review or post approval. However, a cynic might question the multiple spinning plates until such time as there is some visible meat on the commercialisation bones! - focus on the US market and that message came across loud and clear on a number of occasions. I did get the impression that RoW(essentially Europe and Japan) is more of a distraction at this stage. EMA submission later this year but no clear drivers with 12 month approval process. Like Ivy very surprised at how long and also surprised that according to GL little or no collaboration between FDA and EMA. IMO following FDA approval and given desperate need for new ABs that these bodies would make more of an effort to move approval forward across multiple geographies - on commercialisation what was new for me was what was said about commercialisation options now including discussions about a global deal with big Pharma. I was at last year's AGM and all GL's presentations when he was in London last year and year before and as I recall this is the first time global and big Pharma have received as much air time. Ivy, do you share this view? - funding not an issue. More options available that will be decided upon as and when circumstances require and terms suit MTFB - 1-on-1 with Jon Wood after formalities ended and a number of interesting points to note. 1. His CV is on the MTFB website but he elaborated and his fund management and venture capital background could prove very beneficial in terms of attracting the best deal for MTFB. Managed a substantial portfolio at Federated in the small/mid cap sector and very well connected. 2. Talked about big Pharma and emphasised that they would rather pay a premium after approval rather than take a risk before approval even if risk was as low as 5%. Jobsworth! 3. Biotech sector like a pendulum over recent years. Booming post 08 then crashed after Hilary Clinton tried to gain pre-election brownie points Aug 16 talking about price gauging ( many thanks Mylan and Turing Pharma!!). On the upswing now and, looking forward, time looks better for launching new product and access to funds on beneficial terms In summary, a useful meeting which confirmed much of which is already in the public domain. For me the most interesting was the reference to global and big Pharma. The MTFB truck rolls on!! As always, all IMO!

Many thanks for taking the time and trouble for the excellent posts. Good solid progress with Opti

Digger, try HLH BioPharma, a German company that supplies across Europe. They have an English language online shop and you need to order Lactobal LDL-Control. Email info@hlh-biopharma.de if any queries. Like most of Europe they have no problem with English!!

MTP, suggest you ignore! Good with bold statements that can't/never get backed up. Last Friday post on IMM board about an article appearing in the Sunday Times claiming that IMM's lead drug Lupizor was about to be approved by the FDA. Strange given it has only just completed Ph3 and trial results yet to be unblinded!! Challenged in a similar fashion to your post....silence!

Will be interesting to see what reaction to this afternoon's abstract at ProBiota 2018 over the coming days. Hadn't appreciated it is one of three highest rated abstracts as selected by the Scientific Committee. Good to see Opti holding its own in such exalted company and without providing sponsorship!!

Ivy, apologies for tardy response but many thanks for the update. Increasing number of positive notes of late which no doubt will only increase as NDA approaches. In the meantime, MTFB steams steadily in the right direction despite efforts to distract and discourage investors (sp shenanigans a case in point!). I put that down to the calm direction of GL who, as you know, I rate highly. Many other AIM companies could do with a GL, in fact once Iclaprim is approved MTFB might like to try their hand at cloning!! Enjoy the next few weeks!

Likewise Ivy, many thanks. A very well researched piece from Zacks with a level of detail that can only have come through dialogue with MTFB. Positive! We exchanged posts last year about GL's heavy Atlantic shuttle programme. He's been quiet on this side recently which is perfectly understandable given the NDA preparation, conferences and step up in US market interest but would be good to catch up with him before long. I intended on dropping an email to Walbrook to see if they had any idea but in the meantime have you picked up anything given your ties?

Superb post on ADVFN from riskybusiness1 with his thoughts on the current status of OPTI. Well worth checking out.

Understandably, concern has been expressed on this and other boards about lack of analyst coverage on MTFB in the US. This could be about to change and for the good. On Saturday evening Wallbrook emailed a research note from Seaport Global Securities, a mid-sized regional investment bank with offices across the US, initiating coverage of MFTB with a very positive tone. Don't know what the copyright position is so won't include full text (you should have received if subscribed to MTFB email alerts) but two key points, 'We are initiating coverage of Motif Bio plc (MTFB) with a Buy rating and $23 price target' and 'We would be buyers of the stock ahead the expected New Drug Application (NDA) filing in late Q1:18.' Closing price on Friday was $9.45. The bulk of the note covers technical and commercial highlights of iclaprim with which we are very familiar. I hope this encourages further analyst interest as we head towards NDA

Boom, thanks for the link which I've worked through but still have concerns. I assume AGL is working towards Step 3 PMA of the Device Development Process, focusing on approval for metastatic breast cancer liquid biopsies and using data from the University of Southern California's study covered in last week's RNS. You identify some of my outstanding concerns in your post. For example if AGL has been talking to the FDA why do we know nothing about these discussions. Parsortix is a unique technology for liquid biopsies so I would expect the FDA to be working with AGL to ensure studies are constructed in a manner that addresses FDA interests/concerns. Again nothing. If as was suggested in last week's RNS, 'the required analytical and clinical studies targeted for completion by 30 June 2018 studies will be complete' which I presume completes the PMA Step 3 process then one would expect AGL to understand and have communicated the process thereafter and timescales. If I do a compare and contrast with biotech going through FDA approval at an equivalent stage, information that is not being communicated by AGL, for whatever reason, is generally readily available. We have a couple of current common interests in the biotech space which I believe support my view with one good example being MTFB. They have been more than clear about work done with the FDA and timescales. As I posted previously I am very excited about the Parsortix technology but still have major concerns about the endorsement process stage and the communication relating to this.

Thanks m20, it was that RNS that prompted my post. It states that ‘ required analytical and clinical studies targeted for completion by 30th June’ Were these studies specified in conjunction with and signed off by the FDA. If not how will the FDA assess Parsortix? I have not found anything with details of this process. Studies targeted for completion end of June next year. So what happens after that - process and timescales - to gain approval. No information. I’m a lth and a great believer in the technology but despite recent excellent news I have major reservations over the manner in which this exercise is being conducted. For me a lack of substance and imo a suggestion that the BoD are operating on a wing and a prayer

Searched everywhere but drawn a blank hence request for help. When a new drug is presented to the FDA for approval it has gone though a strict, predefined and monitored process which is straightforward and easy to track. There has been lots of talk about agl seeking FDA endorsement and AN has been talking about it for over two years!! However no obvious process or timescales. Arguably the UMSM study could be positioned as equivalent to a drug’s Ph3 the succes of which would prompt preparation and submission of an NDA but there is nothing just AN chat. I’m a lth and believe this device can revolutionise cancer treatment but still needs approval. What’s the process?

2011, don't know how you and others on this board track down stuff like this. Impressive but deepens the mystery. I speak a little Spanish and tracked down some info on Dr Cisneros. Firstly can't find any direct connection with Opti. He's just completed his PhD with a thesis on microorganisms and their importance to humans. This was done in conjunction with and presumably sponsored by a Spanish company Biopolis. To quote their website, "we are a leading provider of mictobial technologies with a strong food ingredients portfolio" In short - probiotics! I wonder if they are about to be announced as another Opti contract?