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@IvySpivey is spot on with regard to CRL being part of an approval process. Before I go any further, I just want to say that I claim no expertise on FDA approval process. I also claim no expertise on analyzing biotech companies.
Having said that, the good news about the CRL is that it only spelled out one point for discussion. Most other CRLs I have read often include at least 3 sticking points. The goods news about the trial results was there were no deal breakers with regard to efficacy or safety (no incidence of death, medical complications, or of hy's law). @IvySpivey is correct in saying that liver toxicity was a major cause for concern when Iclaprim went through the FDA approval process in prior years. So it makes sense for the FDA to subject it the to a higher degree of scrutiny. And as @IvySpivey indicated, in the absence of an Adcom meeting, the FDA is using the CRL as a procedural tool to get further clarification on the liver toxicity results.
In my mind this set back is temporary. The MTFB management team should be faulted for not shoring up the liquidity of the company while the share price was sitting at 40p a few months ago. Regardless of any potential deal that may have been promised to them, they should have never allowed the company to go into PDUFA day with a low reserve of cash. That was a major strategic mistake because the FDA is notorious for coming up with all kinds of frivolous reasons for refusing to approve NDAs. Once approval is in hands, first course of actions must be to raise money and to find a permanent and well credentialed CFO. Jonathan E. Gold even with his MBA has no business taking on the CFO mantle.
I am fairly new to this board so I am not that familiar with some of the hey topics that have been discussed on here since post CRL. However I came across a post by @n4apenny titled "Liver Toxicity" that's helped better assess the range of outcomes to expect from MTFB's meeting with FDA.
I am partially quoting him below and I bracketed in between asterix a very important piece of information. Based on some other reading I did, I think the reason why the FDA is holding up the NDA has to do with the way the data on liver toxicity was presented to them (not as transparent as they would like it to be). As such, FDA wants MTFB to instruct the independent liver experts to resubmit liver toxicity data in a format that will satisfy FDA's documentation standards. Provided this is the case, a reassessment of the updated liver toxicity report will lead the FDA to either:
1) approve NDA without reservation
2) or approve it under the condition that a) the original label is updated and/or b) post-marketing studies are conducted to monitor adverse events related to liver toxicity.
Any of those potential outcomes will lead to a positive re-rating of the share price the minute the much anticipated RNS hits the newswires. This is obviously mere speculation on my part but I am confident in my research and assessment.
Partial re-post of "Liver Toxicity" by of @n4apenny:
"I was reminded yesterday that the BoD fully believed that they would get a tick in the box at the recent FDA review. One of the key reasons for this was that ***MTFB engaged 3 experienced independent US-based liver experts to verify and validate phase 3 trial results. They - the experts - clearly did NOT see anything in the trials which highlighted any worrying liver toxicity concerns or anomalies.*** "
Hi Ivyspivey,
Thank you for your input. Everything you said makes sense to me.
I was in the exact same situation as many on this BB about six months ago. I invested in a biotech company hoping its first drug would get approved by the FDA but it did not. Share price went down by 60% right as the RNS with CRL details hit the news wires. The primary reason why the FDA issued a CRL had to do with lack of sufficient data pertaining to QT Elongation studies.I did some research around the web and it turns out previous companies in similar situations were successful in asking the FDA to either waive QT study or to conduct it as part of a phase IV clinical trial (i.e. FDA will approve the drug for *controlled* commercial distribution). Once I was presented with this information, I went ahead and tripled the amount of shares I owned prior to CRL. Two months later, when the company issued an RNS with details of their interactions with the FDA, they indicated that the FDA wanted them to conduct a 24Hour QT study on a minimum of 20 healthy subjects. The share price went up 120% that same morning and ended up returning to the pre-CRL level within 3 days (300% rise). I sold my pre-CRL shares for a modest profit and I am holding on to the post CRL shares I acquired at depressed prices.
Having said all that, every biotech company dealings with the FDA should be examined both in isolation and in comparison to prior similar cases where available.
My intent in sharing my train of thought with the BB was to get LTH to assess whether it made sense for them to average down if they can afford to do so because the risk reward profile of MTFB looks good for anybody (LTH/STH) buying MTFB shares at their current depressed prices.
Wishing everybody an excellent weekend!
@Jimzi, @30jp, @PrivateRyan
I am not looking to start a debate. I am just sharing my train of thought as it relates to giving consideration to MTFB as a potential investment. I will chime in again once an RNS is issued with details on the outcomes of the MTFB's interactions with FDA.
Good luck all.
The share price is down by more than 85% from its highest levels in mid February. The questions that any opportunistic or rational investor has to ask him/herself are:
1) Not considering day trading activity on MTFB, what's the downside risk on the current share price?
2) Should the company go into liquidation today, will it be sold for about 17 Millions GPB based on the results of the clinical trials up to now along with the addressable market of the experimental drug?
3) Based on what management disclosed from the CRL, what are the odds the FDA will ask for a new set of extensive clinical trials?
4) Based on what management disclosed from the CRL, what are the odds that it will take more than a year for an updated NDA to be resubmitted to the FDA?
If you are not equipped to find reasonable/sensible answers to the questions above, please find somebody who is cause an investment opportunity with a risk reward profile of MTFB (in its current state: 85% percent down with the possibility to at a minimum quadruple based on a binary event to occur on any given day within 60 days) does not come around too often. Do your own and best research on this specs then make your own mind.
GLTAH
Meeting (series of meeting ) with FDA will take place sometime between now and early April.Google "Type A Meeting with FDA" for more details on how it works. MTFB Management will then have to wait up to 30 days after completion of meetings to receive official meeting minutes from FDA. Without meeting minutes in hands, there won't be any RNS on status of discussions with FDA post CRL. I expect that RNS to come out in the second half of April. Until then, the share price is going to randomly move around. It's better for MTFB Management to wait until knowing outcome of Type A meetings with FDA to work out any cash raise. Cause if the path to FDA approval is clear and short, there will be an upward re-rating of the share price which will allow them to raise a lot of of money.
@Cunir: Not official Vevo account. Look up user who posted the video ... username is "ZakariaVEVO". In addition, the video s/he posted was shot with a mobile phone...
My post was littered with typos. Hence the reason I am re-posting an edited version of it.
A fund raise would not be out of question at this point. It all comes down to how aggressively the company is looking at 1) scaling its size and distribution networks and 2) acquiring subscribers/users. In an ideal world, EVRH should have never listed on AIM. Instead, they should have relied primarily on venture capital to finance the growth of the business. Whenever you are tempted to shame the Management team for raising additional money, remind yourself of the following:
-Spotify raised $2.7B prior to listing its shares on NYSE
-Uber has raised a total of $24.2B
-Airbnb has raised a total of $4.4B
-Shopify has raised a total of $253.3M prior to listing its shares on NYSE
Guess what? Most of the companies above barely make any accounting profit. It goes to show that there is a hefty price to pay to grow a digital or any type of business. Having said that, there are ways to grow a company in a cost effective way.
A fund raise would not be out question at this point. It all comes down how aggressively the company is looking at scaling its size and distribution networks. In an ideal world, EVRH should have never listed on AIM. Instead, they should relied primarily on venture capital to finance the growth of the business. Whenever you are tempted to shame the Management team for raising money, remind yourself of the following:
-Spotify raised $2.7B prior to listing its shares on NYSE
-Uber has raised a total of $24.2B
-Airbnb has raised a total of $4.4B
- Shopify has raised a total of $253.3M prior to listing its shares on NYSE
Guest what, most of the companies above barely make any accounting profit. It goes to show that there is hefty price to pay to grow a digital or any type of business. Having said that, there are ways to grow a company in a cost effective way.
@Themis Thank you for your feedback. You have given me very much to think about. I will get back to you in the months and years to come. Take very good care!
Wishing Everybody a great weekend!
PS: Re: YouTube VR.
EVRH has offered glimpses of how they could use YouTube to deliver their content to consumers. Look up "Liam Payne's first headline show in 360 (Teaser)" on YouTube. See 360 Degrees controller on top left corner of video? It's the same 360 Degrees controls found in the MelodyVR videos published on FB.
@BrownAdder
1. would you recommend this Share to anyone and risk your reputation ?
If somebody came to me and specifically requested a tip on a share that could grow 10x over a 5 year period, EVRH is one of several stocks I would recommend. I will offer up the tip without fear of tarnishing my reputation for the simple fact I don't claim to be an oracle and because the future is unknown to ALL of US.
2. whats your understanding on Oculus uptake in US
As a consumer, I don't care about VR (or 4K or 5K or Folding Smartphone etc...) but I do care about how I can make money from a company that is poised to capitalize on it. So I have not been tracking VR uptake. EVRH, as a content company, needs to identify the distribution channels that will provide it with the broadest and easiest exposure to would be "MelodyVR" users (it's their number 2 job after developing a great app filled with wonderful content ). As things stand, the Oculus platform is not the answer unless Oculus can come up with a U$ 99 stand alone headset. Google DayDream/YoutubeVR makes the most sense to me because YouTube is THE online destination for video consumption.... Picture this, if a couple or a family of 4 want to experience VR music together on a periodic basis throughout the year, should EVRH expect them to make an upfront investment of U$ 400 to U$ 800 for the Oculus Go? This option will create too much financial friction on the user's end. AM realizes this and that's the reason why he said the following: "One thing we have noticed is that when we have got amazing artists sharing content we have created on their social media channels, loads of their fans are really excited to get it. The problem is that they haven't got a VR device yet. That is obviously a frustration, so we're looking into developing an iPHONE or ANDROID VERSION of OUR PLATFORM that can work with a VERY LOW-COST VIEWER bundled with content" (From BillBoard Interview: MelodyVR CEO On Building a Global Music Business Out Of Virtual Reality). I am waiting to hear the company's roll-out strategy to various VR content platforms post delivery of new MelodyVR app to Oculus/FB. That will tell me whether the company knows what it is doing...
3. how did you find about EVRH ?
I don't remember exactly. But I do remember that I first looked into VR EDUCATION HOLDINGS PLC. It's very likely I stumbled upon EVRH while doing some research on VRE.
4. did you see much advertisement, locally in US ?
Have not seen any advertisement. If you have followed the company's closely, you will notice that they are just beginning to activate their social media channels. They will likely use the Spotify playbook by focusing much of their advertising effort on the European continent... If successful, US and rest of the world will easily join the Melody VR crowd of EU/UK users.
I hope I answered all your questions to your satisfaction. I regretfully do not have any question to throw back at you.
Wishing everybody a
I have been following this board as a non registered member for a few months now. I have learned a great deal about EVRH thanks to the various comments posted on this board. Just a bit of a background on myself. I am a US based private investor who enjoys looking for US/International micro/nano cap stocks with great potential.
Just wanted to share a few thoughts with this board.
1- The company is not up for sale. There is just too much money to be made over a 5-10 year period. Today, Spotify is a company with a U$ 25B market capitalization. Please take a very close look at the capital structure of EVRH. There are various classes of shares just like FB/GOOG. It's very likely that AM and SH control the majority of the voting rights. This is good/bad but it allows them to run the company based on long term goals and without fear of being sacked by the board/institutional investors.
2- The company is slowly but surely building a quality organization with well credentialed professionals. I am very impressed with the pedigree of the people they have been able to attract to the company. This is across Tech, Music, Marketing, Finance, Film/Music Production etc....
2- As I began buying EVRH shares, the one negative that kept coming up was the slow uptake in VR device adoption. Without a massive number of VR devices in use, EVRH's library of musical VR content is worthless. While FB has been making quite a bit of noise around its VR strategy, very little has been spoken about GoogleVR/YoutubeVR. The Google Daydream headset only costs U$99 and is compatible with about 10 smartphones currently in use & counting (https://vr.google.com/daydream/). Youtube has been quietly rolling out its VR App/Content Library (https://www.theverge.com/2018/11/12/18080210/youtube-vr-oculus-go-app-launch-mobile-vr-video) which is available on both the DayDream & Oculus platforms. In my mind, EVRH would be best served to go the Google DayDream route to accelerate the growth of MelodyVR users. They could give it away as part of a subscription scheme. If Oculus can come up with a stand alone device that sells for U$99 or less, that's even better. Microsoft has been rather tight lipped on its Mixed Reality strategy... They may be able to work with their hardware partners to develop wireless ready U$ 99 VR headsets that are compatible with most Windows 10 PCs.
3- To those who have been wondering about the company's commercial strategy, I recommend that you do a bit of sleuthing on LinkedIn. The company is just beginning to build a commercial function. They recently hired a VP Commercial and a Data Insights & Analytics Manager. I am sure the commercial function will grow larger in the coming months.
4- There is lots of talk about AM, SH, CFO, VP-Creative but folks hardly ever talk about the highly accomplished CMO Nikki Lambert. Understandably, she hardly ever makes public appearances but I think she is the brain behind the commercial/marketing strategy.