Vectura Share Discussion Threads

[popper joe] 12/5/2017 10:07

fhmktg, where have you seen it suggested that Hikma's rejection might be due to the wrong protocol? I did read something to that effect about Milan's rejection.

I was wondering about the wording in yesterday's RNS where it stated that Hikma and Vectura "believed there was a low likelihood of approval this year". I had previously read that a "major" rejection would take 10 months to be reconsidered by the FDA, whilst Numis yesterday said that it presumed there would now be a 12 month delay in the programme. So is the wording in the RNS clutching at straws, or are they aware of something more positive that gives them reason to believe that there is still a likelihood of approval this year albeit "low". If not, why not just say there is no likelihood?

[fhmktg] 12/5/2017 09:28

So, is the consensus that both Milan and Hikma have filed using the wrong protocol?If so it's ludicrous that the FDA leave it to this stage having accepted the file for review!

[richtea1701] 12/5/2017 09:20

Bit of a bummer but got a feeling might just rumble steadily on over next few months anyway. Especially if company provide a confident update. Head of FDA used to be on GSK board I believe. Good to know the old networks are still running the show

[fozzie] 11/5/2017 22:18

Better places to have my hard earned over the next year that's for sure. I'm out for now but will keep on my watch list and hope to come back later in the year.

[dontay] 11/5/2017 19:20

Mylan have said it has disagreed with the reasoning behind the FDA decision because the agency was asking it to comply with draft guidance rather than pre-agreed rules.After all that has been said about Hikma and VEC's work that has gone into ensuring compliance with the FDA's requirements ... it does look like they may be correct and the FDA have moved the goal posts for both applications. It's doubtful now that approval will be forthcoming until this time next year meaning market launch won't happen till autumn next year... 18months from now... that's if all goes well with a new submission. By which time the window of opportunity for a generic may be starting to close. Reports suggest that GSK have already reduced the retail price of Advair by 20% in preparation of seeing off any substitutes and in any case its official replacement will probably be well entrenched on the market by then.

[jdgen] 11/5/2017 16:43

Having worked in both delivery device and asthma/copd companies the latest news is no surprise. VEC expertise is in delivery therefore the least risk, higher risk is relying on approval for any combo product and even higher risk is having own usa sales force. Having said that I am a longterm VEC holder with bulk of stock at the pre 90p level, trading in and out of the stock during the peaks and troughs. Just bought in more at 132 which I see as an overreaction to latest news.

[sikhthetech] 11/5/2017 11:03

disappointing update..
Over the years, we've seen the rollercoaster rides with Skp.. I was hoping to see the share price around 200p by the 1st anniversary of the merger... given it's only a month away, it looks unlikely now...oh well...lol

[aceuk] 11/5/2017 09:32

America 1st innit!

[ianood] 11/5/2017 09:29

Probably correct, cast your mind back to the issues that SKP had with the FDA and flutiform. Because of the cost they eventually gave up!

[fhmktg] 11/5/2017 09:16

Unless it's a supply chain validation issue, my guess is that it relates to bioequivalent delivery of the two components; the FDA is notoriously concerned with these dual therapies for asthma and copd.

[chop55] 11/5/2017 08:52

The good news is found in the PR of Vectura, that says:

'...no material issues were raised regarding the substitutability of the proposed device.'

[richtea1701] 11/5/2017 08:19

Few punters were quick out the blocks at 8 and bought the dip. Patience again. Pull up a chair.

[dontay] 11/5/2017 08:14

Broker Numis reminded Vectura investors that there are three types of FDA complete response letter (CRL) and four outcomes, including a first pass approval, which would drive significant forecast and valuation upgrades; one calling for a "minor" amendment to the ANDA; one calling for a "Major" amendment which can be from a larger number of what are still minor observations to a whole range of more trials. However a typical 'Major' designation takes around 10months to resolve and the wording of VEC's update seems to suggest that this case should not be TOO major! The drop back of the share price shouldn't be too bad before a recovery gets underway again.

[soundbuy] 11/5/2017 08:09

7.50am RNS will have caught a few on the hop.......

[carpadium] 11/5/2017 08:06

Years of expensive R&D screwed yet again by the pernickety FDA.

[alexchry] 11/5/2017 08:06

Very bad news, no approval and no money this year.

[soundbuy] 11/5/2017 08:04

Bad news...............though will come good, just a question of when.........

[diesel] 11/5/2017 07:59

News out, difficult to interpreted full meaning, except it ain't approved yet!

[fhmktg] 11/5/2017 07:14

No news is bad news?

[dunderheed] 10/5/2017 17:35

Reserved for Pram.

[pooroldboy55] 10/5/2017 17:30

And GSK UP 25P

[dunderheed] 10/5/2017 17:11

5997: Yeah hikma mgt, lol!

[pooroldboy55] 10/5/2017 17:00

Think it could be more than spec someone knows something but not us.