News from the FDA regarding Sarepta and comments on the continued move up in the markets
Click download link to listen on this device: Download Show
Comments made in this editorial regarding Sarepta Therapeutics reflect only the personal opinions of Chris Temple, Al Korelin and Cory Fleck and are not meant to be construed as investment advice.
LPG:
James F is pretty good. We posted a link to his prediction of a gold share top last month and he seems to have been two days from the top. Today we touched the two points on the XAU and HUI that for him confirms a major correction is on the way in gold shares. I was thrilled to have been able to share him with my readers.
I think he nailed it yet again. And I am eagerly awaiting his call for a low in the correction. I think that many people agree with me that we have seen the bottom in gold and a higher low in the current correction will verify that we are once again off to the races.
https://zd105.infusionsoft.com/app/form/321-gold-registration
LPG, when are you going to review my book? It’s #1 in class on Amazon.
Hello Bob,
Thanks for the heads up on James, and, again, for bringing him to our attention in the first place.
I was utterly disappointed AND frustrated you forgot me during your last stay in the Alps.
You promised me we’d meet/have a drink/go for a flight under the Eiffel tower again or above the “Bonne Mere” statue in Marseille… and nothing… (radio) silence…..
I called you MANY times on Skype and you never picked up. Di-sa-ppoin-ting.
I understand our relationship is not what it used to be… but you could have made an effort.
Still love you though.
LPG
🙂 🙂 🙂
Typo:
It’s James FlanAgan, not FlanIgan.
LPG
Reading Pane: UPDATE 3-FDA delays decision on Sarepta’s muscle-wasting disorder
drug
* Sarepta shares rise as much as 26 pct to $23.24
* Analysts say chances of approval still low
(Updates shares, adds CureDuchenne comment)
By Amrutha Penumudi
May 25 (Reuters) – The U.S. Food and Drug Administration
deferred a highly anticipated decision on whether to approve
Sarepta Therapeutics Inc’s muscle-wasting disorder
drug, a month after an advisory panel determined that the
treatment was not effective.
Sarepta’s shares were up 17.6 percent at $21.69 on Wednesday
on hopes that the delay could mean that the drug, eteplirsen,
may still be cleared for sale.
Eteplirsen was developed to treat Duchenne muscular
dystrophy (DMD), a rare condition that typically emerges in
boyhood, causing weakness in the arms and legs, and eventually
the lungs and heart. Patients often lose the ability to walk in
adolescence.
Patient groups and parents have been arguing passionately in
favor of the drug, saying children had benefited from it. There
is no other treatment on the market.
Sarepta said it had been told by the FDA that the agency was
unable to finish its review by Thursday as planned but would try
to complete it in “as timely a manner as possible.” [nBw336WlLa]
However, analysts said the chance of approval was still low,
noting that the FDA had also delayed a decision on BioMarin
Pharmaceutical Inc’s DMD drug before rejecting it.
[nL3N14Y4X0]
“We continue to expect no near-term approval,” SunTrust
Robinson analyst Edward Nash wrote in a client note, adding that
he expected the FDA to make its decision in mid-June.
The deferral, however, buys time for parents and DMD
advocacy groups to put more pressure on the FDA.
CureDuchenne, a nonprofit organization which provided early
funding to Sarepta for the development of eteplirsen, said it
appreciated the care the regulator was taking in the review of
the drug.
“We cannot afford to lose another generation of boys to
Duchenne because there weren’t treatment options. It is urgent
that we get the right combination of approved treatments for our
boys,” founder and CEO Debra Miller said.
An FDA advisory panel said last month that Sarepta’s
clinical trial of 12 patients did not provide substantial
evidence that the drug was effective. [nL2N17S0X4]
The panel announced its determination at an emotional public
meeting at a hotel in Hyattsville, Maryland after more than 50
patients and family members pleaded for the drug’s approval.
While most analysts see the panel vote as the end of the
road for eteplirsen, the FDA has in the past ignored a negative
recommendation from the panel in the face of strong advocacy.
Up to Wednesday’s close, Sarepta’s stock had fallen 42
percent since BioMarin’s rival drug was rejected.
(Reporting by Amrutha Penumudi in Bengaluru; Editing by Don
Sebastian and Ted Kerr)
((penumudi.amrutha@thomsonreuters.com; within U.S. +1 646 223
8780 outside U.S. +91 80 6749 4486; Reuters Messaging:
penumudi.amrutha.thomsonreuters.com@reuters.net))
Keywords: SAREPTA FDA/
Created on May 25, 2016 12:49:4R8 ePaMdingPane_d4145142-0110-49b2-8ee8-0ea93570c248 Page 1 of 1
A dynamic here that has not been discussed too much is that of a defined congressional mandate. Unlike was the case with two other DMD drugs where there were safety issues, Sarepta’s eteplirsen (with no safety concerns) has been pushed as well by over 100 members of Congress and Senators. Among the other considerations, FDA mucky-mucks in this case are likely feeling that pressure, too.
This is still looking very weak to me. I am open to things breaking out to the upside in conventionals but very wary of this market giving back the past few days.
Hope everyone is doing well today.
I mentioned yday on the market wrap that I’m quite bullish on US conventional mkets going into 2017, where I expect much higher levels on the S&P.
Below is a link to a video recording of James Flanigan of Gann Global Financial (again, thanks to Bob Moriarty for bringing this gentleman to our attention).
If my understanding is correct, James makes the case for a major top being close (in time) in US conventional markets, which is not my personal view.
So just video is food for thought. Keep in mind that James has about 200yrs of historical data on the US mkets to back up his views (translation: I need to pay strict attention… and I have to admit his video and the stats got me scratching my head)
http://www.gannglobal.com/webinar/2016/May/16-05-EWI-Video4.php?inf_contact_key=9a59c8f7778c3a42dd03bad22eeb5a86893311aee981bd57f747bf1e00414ee2
Best to all,
LPG