Summit Therapeutics Share Discussion Threads

[luminoso] 28/9/2016 11:40

Good point football.

[football] 28/9/2016 10:38

RG sold a few % in blinkx/1R and they turned up in a off shore account a few months later and the share price has doubled since then

[patviera] 28/9/2016 10:25

SomeuwinSmell the coffee mateIt means one thingHe ain't sold a share for years and suddenly does!!Mark my wordsA heavily discounted placing coming!!

[hugus maximus] 28/9/2016 10:25

someuwin .. but Jim Mellon is still in and some of us have the occasional banter on twitter with him .. he's clearly still a fan. Perhaps Griffiths simply moved his money to something he considers to be more important.

There'll be no lack of confidence here, once I know how Glyn plans to finance the next advance.

GLA

[luminoso] 28/9/2016 10:22

Griffiths may have needed the money ! I believe he has serious paper losses elsewhere - AUE for one - and others where I have been involved over the past few years.

[someuwin] 28/9/2016 10:12

Griffiths could be out altogether now for all we know.

Not a great vote of confidence.

[patviera] 28/9/2016 09:55

So Griffiths has sold over 2pctMust mean a placing coming if he's selling?!!!That is why I won't be buying another share hereDon't trust Glyn

[waterloo01] 27/9/2016 15:10

Hyper, IF it's continued after next week the benefit is rather tied to EZ getting approval. If it does, it certainly adds that sort of sum to any market cap, but IF it gets approval, that will seem like a nice to have!

Re approval, the more I read the more I think we could go for approval after our current 40 boy trial, rather having to wait for any placebo trial.

The read through to us from the SRPT decision seems clear to me. We are safe, the bar for showing biologic activity has been set very low and hopefully the current trial that starts to report in 2017 will show clinical activity (again bar has been set low here).

"So, what is the lesson? One, no, the FDA did not lower its standards in the approval of eteplirsen – the drug is safe and has biological activity, as well as clinical activity seen in a non-randomized study. Two, the FDA needs to ask its AdComms direct, unambiguous questions that capture their approvability recommendations. Had they done so, there would have been no second-guessing and no Sturm und Drange over their decision to approve eteplirsen"

[solomon] 27/9/2016 13:13

I'm beginning to think it was a good idea after all to go out to USA. Without the presence of SMMT on Nasdaq there would surely be fewer RNS's

[patviera] 27/9/2016 13:08

Freedosh Stick to investing in tech companies As u know nowt about summit and biotech You ramped these at 250p and now write such rubbishI'm putting u on filter as don't trust u

[freedosh] 27/9/2016 12:21

Whatever is the ex NHS finance guy Hip up to? Stick to bean counting Hip since you clearly haven't a clue about bacteria. Reds drugs are not for C Diff so how does that make RDZ worth a quarter of yesterday's value?
Are you short?

[abergele] 27/9/2016 12:14

You could be right Luminoso

[luminoso] 27/9/2016 12:12

abergele - I think the tick up was in anticipation of the effect that RNS might have.
Re trades - thanks for your explanation.

[abergele] 27/9/2016 12:09

Luminoso,,,just todays in my book,,,those 13.00pm ar yesterdays,and I'm not going back there for now...they were all in the price then and now...

[waterloo01] 27/9/2016 12:08

Lets hope they renew the priority review vouchers as have major value, AbbVie bought one in August for $350 million.

[luminoso] 27/9/2016 12:04

More good news.

[abergele] 27/9/2016 12:03

A delayed sell of 15k plus,and we tick up on the bid,mmmmm
are we going to show a delayed large buy later ,,interesting times
bids up again,mmm

[football] 27/9/2016 12:03

Summit Therapeutics plc Summit Received Rare Pediatric Disease Designation From Us Fda For Ezutromid In Treatment Of Dmd
27/09/2016 12:00pm
UK Regulatory (RNS & others)


TIDMSUMM


Summit Therapeutics plc

("Summit" or "the Company")

SUMMIT RECEIVES RARE PEDIATRIC DISEASE DESIGNATION FROM US FDA FOR
EZUTROMID IN TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY

Oxford, UK, 27 September 2016 - Summit Therapeutics plc (NASDAQ: SMMT,
AIM: SUMM), the drug discovery and development company advancing
therapies for Duchenne muscular dystrophy ('DMD') and Clostridium
difficile infection, today announces it has received Rare Pediatric
Disease designation from the US Food and Drug Administration ('FDA') for
ezutromid in the treatment of DMD. As a utrophin modulator, ezutromid
has potential as a disease-modifying treatment for all patients with the
fatal muscle wasting disease DMD, regardless of their underlying
dystrophin gene mutation.

"Rare Pediatric Disease designation builds upon the Fast Track and
Orphan Drug designations which the FDA has already awarded to ezutromid,
recognizing a significant unmet medical need in the treatment of DMD,"
said Glyn Edwards, Chief Executive Officer of Summit. "We plan to
leverage these regulatory advantages in the continued clinical
development of ezutromid, which is currently in a Phase 2 clinical trial
called PhaseOut DMD, to bring ezutromid to patients in need as quickly
as possible."

The FDA defines 'Rare Pediatric Disease' as a disease that primarily
affects individuals aged from birth to 18 years and affects fewer than
200,000 persons in the US. Under the Rare Pediatric Disease Priority
Review Voucher programme, a sponsor who receives an approval for a drug
or biologic for a 'rare pediatric disease' may qualify for a voucher
which can be redeemed to receive a priority review of a subsequent
marketing application for a different product. The Priority Review
Voucher is requested at the time of the marketing application and
awarded upon approval of the product. The voucher may only be used once,
but may be sold or transferred an unlimited number of times. The Rare
Pediatric Designation follows on the recently granted Fast Track
designation by the FDA for ezutromid. The Rare Pediatric Priority Review
Voucher programme is set to expire on 1 October 2016, although the US
Congress is currently considering legislation to extend the programme.
If the programme is not renewed, the FDA will no longer award pediatric
vouchers to otherwise eligible sponsors.

[football] 27/9/2016 12:02

so is it £3.20?

[someuwin] 27/9/2016 11:58

N+1 Singer have issued an update on SUMM today. Can't find the details yet.

[luminoso] 27/9/2016 11:57

which trades are surely buys - all of them ?