Would you buy the company for $500 million if you were the president of a small pharma?
Is ACTC doing any trials in Portugal?
"Stem cell treatment causes nasal growth in woman's back" - July/2014
A woman in the US has developed a tumour-like growth eight years after a stem cell treatment to cure her paralysis failed. There have been a handful of cases of stem cell treatments causing growths but this appears to be the first in which the treatment was given at a Western hospital as part of an approved clinical trial.
At a hospital in Portugal, the unnamed woman, a US citizen, had tissue containing stem-cell-like cells taken from her nose and implanted in her spine. The hope was that these cells would develop into neural cells and help repair the nerve damage to the woman's spine. The treatment did not work – far from it. Last year the woman, then 28, underwent surgery because of worsening pain at the implant site.
The surgeons removed a 3-centimetre-long growth, which was found to be mainly nasal tissue, as well as bits of bone and tiny nerve branches that had not connected with the spinal nerves.
The growth wasn't cancerous, but it was secreting a "thick copious mucus-like material", which is probably why it was pressing painfully on her spine, says Brian Dlouhy at the University of Iowa Hospitals and Clinics in Iowa City, Michigan, the neurosurgeon who removed the growth. The results of the surgery have now been published.
the chartists are on a losing streak.
You should be more concerned with the loss ATRS will report then the revenue since that's going to have a bigger impact on the shareprice.
The twins must be declining to some extent. They were strong enough to hand out water at the race a year ago & now the mother thinks its to physically challenging.
Whose going to buy that junk? They've manipulated the stock up from $3 - $12 & now their going to dilute it by at least 50% & sell it for a huge mark-up on no new data.
most knowledge of whats going on in the DMD community. That's a scary thought.
DELAYS IN GENERIC DRUG APPROVALS – 30-MONTH STAYS
"Patent listings are important in the generic drug approval process because challenges to listed patents can lead to stays in approval. The FD&C Act requires that generic drug applicants include, in their ANDAs, a certification for each patent listed in the “Orange Book” for the innovator drug. Similar information is required for applicants filing 505(b)(2) applications under section 505(b)(2) of the FD&C Act."
"Under FDA’s traditional interpretation of the Hatch-Waxman Amendments, multiple 30-month stays have been possible. Submission of newly issued patents after an ANDA application has been filed with FDA has required the appropriate certification and notice to the NDA holder and patent owner with the possibility of a 30-month stay if patent infringement litigation resulted. As a result, there have been a number of instances where there has been more than a single 30-month stay. These include paroxetine hydrochloride (Paxil) and gabapentin (Neurontin)."
Paragraph 1 - ATRS's patents were not listed when Medac filed their application so notice to ATRS was not required.
Paragraph 2 - Medac filed their application but subsequently ATRS's newly issued patents were filed.
This seems to indicate to me that Medac should have notified ATRS. I'm not sure the automatic 30 month stay is applicable to 505(b)(2) filings but I'd say this gives the FDA an open door to delay Medac's approval.
I looked back at the price movement when the 120 week data was reported. The stock was trading for $20 at the close on 1/15. On the day of the PR the stock opened at $23 with a high of $28.80. Within 6 trading days the stock traded down to $22.90.
If the 6mwt shows a decrease of anything more then 5% then I imagine the stock will trade down. If SRPT reports a 10% decline then we might see it trade back to $20.
The risk doesn't seem worth holding & it might be better just to buy once the data is reported.
Somebody convince me why I'm wrong.
There's also the question between "filed" & "accepted" which is normally 2 months. This is another reason the lawyers will be the only winners.