Btg Share Discussion Threads

[semper vigilans] 14/6/2018 21:43

Oh dear - major change is needed - clawback of option profits?

[cockneytrader] 14/6/2018 21:07

Black Friday for BTG me thinks. Grim reading, especially the unsuccessful coil removal.

[cockneytrader] 14/6/2018 20:58

After reading all the FDA comments, this doesn't stand a chance, IMO. It's like a very bad piece of homework!

hxxps://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/AnesthesiologyandRespiratoryTherapyDevicesPanel/UCM610399.pdf

[fhmktg] 14/6/2018 20:36

Bit late, but you can read the PneumRx and fda briefing documents online, just Google fda PneumRx.The data and arguments contained are complex and of course the fda document asks some tough questions.It's not easy reading, because we are dealing with patients who are desperately ill and for whom the available treatments aren't very effective.It will be a tough call!They ARE seeking approval, rather than simply updating information.

[cockneytrader] 14/6/2018 20:25

From the FT, says approval looks unlikely.

[cockneytrader] 14/6/2018 17:53

BTG are about to enter the perfect storm - it seems that everything that can go wrong is going wrong!

[fhmktg] 14/6/2018 17:31

We'll find out later today or tomorrow, but a scan read of the UCM document relates to a post approval market approval trial- not unlike the phase IV trials that drugs have to undertake to demonstrate real patient experience.Keep the faith, the document notes that over 2000 patients have already been treated in the US.

[cockneytrader] 14/6/2018 16:43

It gets worse. Recruitment over 2 years with a 3 year follow up. That's 5 years in total!

Let's hope they just wave the trial and are happy with data from ELEVATE.

[bill hunt] 14/6/2018 16:19

Not having the full report but the post. It would seem that the study is in a post approval setting. Note not a pre approval setting. Needs clarification as to if it has been approved or has to be approved.

[cockneytrader] 14/6/2018 16:04

I beginning to think that BTG were sold a pup!

[cockneytrader] 14/6/2018 16:02

Sounds like they have to be approved before this trial can start.

[cockneytrader] 14/6/2018 16:00

Bill. The lung coils.

[bill hunt] 14/6/2018 15:58

Which product is the FDA APPROVED PRODUCT in the second sentence?

[cockneytrader] 14/6/2018 15:55

A quick glance indicates another 2 year study in 30 US cities.

'This PAS is a single-arm, prospective, multi-center Study. It is designed to assess the 12- month safety and effectiveness of this FDA approved product in a post-approval setting, and to support the continued assessment of the ELEVAIR Coil therapy for the treatment of severe emphysema in the United States. In addition, data will be collected to assess healthcare utilization of the ELEVAIR Coil therapy.
The PAS will enroll a minimum of 300 Subjects over a 2-year period. Up to 30 US sites are expected to participate in the Study. All enrolled Subjects who undergo the ELEVAIR Coil therapy procedure will be monitored for outcome data from baseline through 3 years following their first ELEVAIR Coil procedure.'

[cockneytrader] 14/6/2018 15:41

FDA meeting document

hxxps://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/AnesthesiologyandRespiratoryTherapyDevicesPanel/UCM610416.pdf

I have not read it yet.

[billbailey1] 14/6/2018 15:14

There's a £150m impairment on this product over two years. It seems to suggest that if today is bad news and sales get put back either the impairment will increase or the product pulled

[cockneytrader] 14/6/2018 13:12

From close period statement

'These include initiating the ELEVATE clinical study to generate additional data to support market development, and progressing the Premarket Approval application in the US, where an Advisory Committee Panel meeting is expected during the summer with potential approval by the end of 2018.'

Fhmktg. You may well be correct - if that is the case approval by the end of 2018 is a pipe dream.

[fhmktg] 14/6/2018 11:03

CT I'm not sure it's a voting meeting, but rather to share info and give guidance on what else is needed.Btg already have eu clearance but, as always the fda will want to add bells and whistles- particularly on where unmet needs are identified and cost savings claimed.I agree it could make a further delay of 1-2 years before revenue.They may allow a named patient basis for trials or an 'orphan' allowance because there is no drug free treatment around.

[cockneytrader] 14/6/2018 10:41

The FDA meeting is scheduled today, so we will know the outcome tomorrow in an RNS. I believe this will be make or break for the share price. I don't know which way the FDA will vote, but I would imagine they will want to see the data from the recently announced ELEVATE trial.

[waterloo01] 13/6/2018 16:19

I'd love to say I was back in here but the reasons that have been known for more than a year all still stand. (mainly CroFab competition, stuff going off patent and Varisolve disappointment). I'm not sure what they have that warrants a valuation still over £2bn.

[billbailey1] 13/6/2018 15:46

Anything can and will happen with this share. For those of us currently holding it's beginning to look like a looooong year ahead

[cockneytrader] 13/6/2018 10:58

For a share to fall 20-50% is not at all unlikely if they issue a clanger of an RNS. There are numerous recent examples, see Microfocus. That is exactly why I am not currently holding. Varithena is a problem, and they will have to make a decision on that product sometime in the next 6 months. CroFab, a star performer, faces competition as of Oct 18 from Anavip - it's an incredibly small market!

PS sorry I am boring you all