I have a question regarding Sarepta Therapeutics seeking FDA approval on their new drug?
So this company came up with a drug that treats a rare disease very effectively..........
and it seeks approval from FDA for an accelerated fast-track approval...........
(it's decision will likely impact its stock price dramatically)...........
here's my question:
Are we going to know WHEN this wll happen?
like, will it be posted on this calendar?:
or is the date of the decision just going to be a surprise?
Here's what 'm thinking: If we know when it is scheduled,
and if the decision is going to take place while the stock market is open.....
you could buy the stock, and enter a "stop loss limit order".........so you get all the upside but none of the downside.
what do you think?
- underexposed...Lv 77 years agoFavorite Answer
Drug companies and FDA approval....you are ASSUMING the fact that because the drug is being fast tracked that this is a slam dunk.....I can tell you from bitter personal experience in my past....this is not the case.
First of all....THERE IS NO PHASE 3 FDA APPROVAL testing being done on their leading drug, eteplirsen.
You are getting caught up in the hype surrounding the possibility of this drug getting the approval
So far the drug passed Phase I which means the drug at suggested dosages won't kill the patient....it passed Phase 2 which means their has been a very limited study on patients and the drug shows promise.
Phase 3 (and this is the killer) is where there is a huge trial, refined dosages and an extensive evaluation is performed to see if there is a significant medical value to convert it to a marketable drug.
THEY HAVE NOT EVEN STARTED SUCH TESTING YET!!!!
Read that bit of MARKETING FLUFF that is in that link.....there IS NO FAST TRACKING....they have not even talked to the FDA yet....and do not have their approval yet to even start the Phase 3 trials.
Such trials take the best part of a year...(a couple of months to assemble the candidates for the trial) a couple of months to conduct the tests, a few months for them to assemble the data and a few months for the FDA to review the data....potentially more months if the FDA finds the data wanting in some area and demands further testing.
Read this statement from that link from March 24/2013
"Failure to seek accelerated approval would delay the drug's potential approval and could suggest the FDA has concerns. That could cause the shares, which closed at $32.77 on Friday, to decline into the $20s."
Does that sound like a slam dunk to you?
Lois...you must learn to investigate things like this further and not drink the Koolaid from pumpers. Drug companies seeking FDA approval are prime PUMPER material.
"or is the date of the decision just going to be a surprise?"
they have not even asked for permission yet for Phase 3 testing...never mind being "fast tracked"
here is an earlier link from Oct 2012 when the Phase 2 results came out and the stock was pumped for fast tracking (NOTE: that was 4 months ago and the company is just now going to ask for a Phase 3 trial)
Even this MEDIA PUMP had a caution
"On the negative side, you can't dismiss the risk that comes from a tiny study of just 12 patients. The data are not pristine -- remember the two patients in the 30 mg eteplirsen dose who were excluded from the analysis because they experienced rapid declines in walking ability. FDA may simply conclude that more clinical data is needed for approval."
12 patients is hardly a decent sample size to judge the effectiveness of the drug ....especially when 2 (almost 20% of this study) had to withdraw due to problems with the drug.
Learn to evaluate these drug promises....I can speak from experience....8 years ago I had money in a company called Medicure (MPH.v) it had a drug to repair the heart after heart surgery. Early testing showed it to be a winner...I was in heavily at $1.20/share....when it announced a fast tracked Phase 3 testing....I bought more (very naive back then)...one day ...overnight the failure of the test was announced and the stock price dropped to $0.80... later the stock is worth about $0.30 ...I took a huge loss....and soured me on this type of stock ever since.
EDIT: it is totally up to you....I have expressed my feelings on this stock. You still believe a 12 person trial is going to convince FDA to even allow the test for Phase 3 (this is hardly a definitive study)...I also read that they have competition from another drug....coming second rarely wins much....it will be at least a month before FDA makes a decision to allow a phase 3 trial then about a year after that before a result is announced
I HATE this type of stock for reasons stated....very unpredictable.....I can say no more