Summit Therapeutics Share Discussion Threads

[freedosh] 20/9/2016 19:55

In theory we could go for early approval in the other 85% for whom no genetic corrective therapy is, as yet, currently available.

[sorrento06] 20/9/2016 19:50

It must do, SRPT is only able to treat less than 20% of mutations and got early approval based on the lack of treatment available for DMD suffers. SRPT news is a game changer for Summ.

[freedosh] 20/9/2016 19:50

As a rule you have to run a Phase III against the approved drug, if such exists. It's down to the FDA ultimately but I feel evidence of clinical efficacy could swing it after Phase II. Patient/family pressure will play a key role.
Good that we have a US presence, IMO.

[waterloo01] 20/9/2016 18:25

One for the pipe. SRPT ran their trial on 12 (11) boys. The confirmatory trial they will run for 2 years will use two different doses. It is not a placebo trial. Western blot was key.

Our phase 2 open label will have 40 boys on it. As the FDA have given the green light to this as an outcome (western blot) without a placebo trial, what is stopping us also applying for approval after our 40 person trial in 2017? Not the route the company has stated, but does the SRPT approval change the goal posts?

[sorrento06] 20/9/2016 09:24

Must be a buy.

[sorrento06] 20/9/2016 09:23

Omg, is that sell for real!

[freedosh] 20/9/2016 09:09

Back on the front page of risers at No. 23 It's been a while!

[hyper al] 20/9/2016 08:55

nice to see some volume

[sorrento06] 20/9/2016 08:06

I think we will see some big buys today! So much potential upside now before the end of the year.

[algernon2] 20/9/2016 00:33

"Summit Therapeutics joins Sarepta's party; shares up 16%..."

[chrisatrdg] 19/9/2016 20:23

Per gmcc this evening adding further detail:

'RE:SRPT Approved in USToday

Hi everyone some good info shared recently many thanks!

Yes great news for DMD Exon 51 boys ! . Good for SMMT /SUMM as FDA precedent set !



“The accelerated approval of Exondys 51 is based on the surrogate endpoint of dystrophin increase in skeletal muscle observed in some Exondys 51-treated patients. The FDA has concluded that the data submitted by the applicant demonstrated an increase in dystrophin production that is reasonably likely to predict clinical benefit in some patients with DMD who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping. A clinical benefit of Exondys 51, including improved motor function, has not been established. In making this decision, the FDA considered the potential risks associated with the drug, the life-threatening and debilitating nature of the disease for these children and the lack of available therapy.

Under the accelerated approval provisions, the FDA is requiring Sarepta Therapeutics to conduct a clinical trial to confirm the drug’s clinical benefit. The required study is designed to assess whether Exondys 51 improves motor function of DMD patients with a confirmed mutation of the dystrophin gene amenable to exon 51 skipping. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.”

Good luck everyone !'

[chrisatrdg] 19/9/2016 20:20

Explains basis that approval has been given by FDA:

Here’s Why Sarepta Therapeutics Inc Is Up 80% Today (SRPT)

[luminoso] 19/9/2016 19:24

Thanks for that info re Wainwright,waterloo. I was on the road and seldom online. Interesting developments today.

[patviera] 19/9/2016 18:13

If Glyn gets sacked or leaves I will increase my holding in summit 10 foldUntil then I hold a small number is shares as I don't trust him

[waterloo01] 19/9/2016 16:21

SRPT market cap now $2.5bn v $83m.

I think the read through should be interesting.

[chrisatrdg] 19/9/2016 15:48

SMMT on NASDAQ up again

Summit are currently up again on NASDAQ was by 12.27% at $6.68 on high trading levels now 14.62% at $6.82 following similar levels to last Friday. I guess SRPT news may help now that the word is out that Summit's DMD drug could be for 100% of DMD boys

[waterloo01] 19/9/2016 15:08

Blimey. SRPT approved. Up 75% and trading halted.




Edit: Make that SUMM $65m v SRPT $2bn.

[waterloo01] 19/9/2016 10:46

"The Firm or its affiliates did not receive compensation from Summit Therapeutics plc"

[luminoso] 19/9/2016 09:45

Is wainwright independent or paid research ?

[waterloo01] 19/9/2016 08:54

The note talks about potential peak yearly revenues with Ridn'azole (RDZ) $1bn by 2021 and Ezutromid $1.2bn by mid 2020's.

[chrisatrdg] 19/9/2016 08:41

Great find waterloo01 Twitter does have it uses after all will be interesting to see share price in US this afternoon.

[waterloo01] 19/9/2016 08:21

Some interesting tweets over in the US from the HC Wainwright note. A couple of well followed traders seem to have taken a position. Finally nice to see someone making the comparison between values of SMMT and SRPT.

Tweets not quite where one would expect!

Expect a decent bounce on Nasdaq later following the buying on Friday.


(posts on 15th, has a decent number of followers)





And this:

[buywell3] 19/9/2016 01:31

Cash burn in now increasing

Cash pile is getting smaller

When is the next tranche of shares going to be sold and at how much this time ?