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Vernalis Share Discussion Threads
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|Not a pharmacokinetic or formulation issue? Did they mention labeling? If it was something simple then why not say so. Was it a safety issue? Why not say if it was or was not? Investors have the right to be kept fully informed. The FDA are serious people-don't issue complete response letters wily-nily. Are other products with similar profiles going to be similarly challenged? Can cost millions and take years to challenge the FDA or get them round to your way of thinking. RNS too vague to be sure this is not finished imo, and if Tuzistra sales don't start taking off Ver could be in in deep trouble imo. Also lack of news on Moxtag a concern imo for investors. Having started with huge cash pile this could easily be frittered away given costs of running an expensive mgmt team, sales force, regulatory hurdles etc. Without serious good news on sales, deals, approvals etc today's share price could look expensive before the year is out. imo|
|Vernalis is not getting product approval anytime soon. The 'delay' is due to their development partner and contract manufacturer Tris Pharma having an unsuccessful FDA inspection. This has put all development data into question along with the production of the registration batches. Tris has been told by the FDA that they are moving forward with a warning letter, which will put all product approvals on Hold from that facility for at least a year. Vernalis is screwed - should have picked a better business partner than Tris PHarma. Sell now....|
|Let's wait for a fuller explanation of what the FDA want.If it's just a labelling detail, then just a short delay. If they are after further data which requires testing then VER could miss the tight time schedule to be ready for next season.We should get more clarity once the FDA letter has been studied.|
|'Delay' seems over reaction, not 'failed'........|
|PDUFA for ts- 07 Thursday.More ammunition!Please get Moxatag supply resolved asap,then the sales team can really get cracking.|
|Remember the pattern last year was that only about 16% sales occurred prior to end December, the rest after. The June update should be a huge improvement on prescriptions and revenue and answer a lot of questions that the H1 figures couldn't. I have to say I was not overly impressed by the CEO on the conference call, and even less so by his unjustifiably massive pay packet. The CFO though seems clued up. I didn't like how they were so keen to play down the severity of the flu season this year and while it was only slightly up on 2015 prior to Dec the extent and severity of flu across the US after Christmas 2016 was massively up on the prior year. That is why H2 figures will be so revealing. Make no mistake if T-XR isn't heavily prescribed during a severe season like that then it never will be.
We are ideally hoping for a Moxatag update asap, the longer that issue goes on the less likely a satisfactory resolution will be found. The ideal solution here is for the new contract pharma manufacturer taking over the old Suir site to take on production but Moxatag needs to be as cheap as possible (at least under $20) to justify it's use over ultra cheap (but multi dose) alternatives like standard Amoxicillin. The key will be ensuring it can be produced cost effectively enough to be a valid sell for patients where compliance is a major concern.
Personally I was always sceptical about Moxatag, I'm not sure it's the right product for Vernalis to be selling and I think they paid far too much for the US rights. Perhaps I have misunderstood the product but I believe the drugs only benefit is that it can be taken once a day versus twice a day straight Amoxicillin but costs considerably more.
I'm have much more faith in the cough cold products simply based on the massive market available there.|
|Indeed, just thinking yesterday that a firm base had been established...let us hope the sales team are selling.!|
|Slow and steady rise from the double bottom of early March.Hope the June update confirms.Could do with a firm answer on Moxatag|
|Nice sustained buys this morning!Not day traders?|
|@buywell3 What do you want, a medal?
June results, revenue from T XR and position on Moxatag, will decide this company's fate.|
|Big note out from Edison today, they seem to have moved back over 80p DCF value..........|
|I see this has dropped over 10p further since I posted
2 Nov '16 - 05:15 - 1489 of 1574 0 0 Edit
Do you guys realize that not all drugs that get FDA approval go on to sell in a way that makes the parent company any lolly ?|
|updated the 3 day chart in the header to a 10 day chart which I think is more useful to see recent prices|
|i thought so too. :-)|
|thanks for posting novandi - an interesting and comprehensive read - I've added the link to the end of the header|
|interesting read for those interested in VER:
|Market currently obsessed with central bank manoeuvres and nothing else, positive news released elsewhere e.g. GSK also largely being ignored.|
|that's what I was thinking, doesn't make a lot of sense really!|
|News of €2 million upfront payment from Servier largely ignored today|
|Somebody is building a stake, 400k bought this morning.|
|Unfortunately thin news flow until June may not provide the necessary interest needed to improve the share price beyond pre-update levels but there is the possibility of early resolution to the moxatag supply issue and further research milestones. Most other news expected H2.|
|Chunky buying today.|