"However, I think that the interim VX-661 Ph 2b trial reading was inconsistent with previous results. This was a tiny trial with only 20 people receiving the drug combo"
If so, are they not required to disclose the results, nevertheless, and give their reason as to why we should not pay attention to the unexpected low results? Another question, if the phase 2b numbers were so small that management could ignore the results why then run such a small numbers of patients? Also if they were so sure that the results would be good why not just skip the phase 2b and go straight to phase 3 by saving a lot of time and also the cost?
I am not criticizing the management but I am just trying to find out the reason behind the management's actions and disclosures.
Third, thanks for the info. yahoo chose not to report that,
Anyway, it is just crazy. One wonders about analysts' opinions.
4 analysts read the same quarterly report and listened to the same conference call. One upped target from 129 to 155, one reiterated buy, and two downgraded to a hold. As I said it is just crazy!
"does this make sense? What is it that they do not want us to know?"
Papa, I think, his statement was probably based on extrapolating the 2013 phase 2 results of Ivacaftor +661. Of course, I could be wrong.
However, if in fact he was basing it on the recent phase 2 data which has not been officially reported then he may have violated the proper disclosure rules in my opinion. Again I could be wrong about that too.
"even though the ceo publicly stated repeatedly that he had available drug!"
The CEO said he only had 10 dozes of the drug and was appealing to various sources to provide funds for the production of additional dozes but no other sources including US government came forward to provide funding.
No wonder that with only 10 dozes being available non of the doctors wanted to deal with such a limited resource.
" If he knows that results are not bad how can he justify to claim that there is no way to comment on the results?"
I think the statement that results "are not bad" was poorly worded in that what he may have meant to say was that based on past data "we do not anticipate bad results."
Smart management is very careful not to imply that they know any results until the data is un-blinded, analyzed, and ready for official reporting.
" It might mean more regulation
Not with Republicans in charge of both the house and senate.
Two idiot analysts downgraded for reason that the quarter report and the presentation was not "exiting."
This is despite better than expected revenue and less than expected loss.
I would not be surprised if they had made their decision well in advance and that is why PPs went down for the past 4 to 5 days from $125+. I bet they told their favorite clients to sell and short before they downgraded.
Fourth quarter GAAP revenues came in at $144.6 million, above the expected revenue of $137.49 million and ......
Total non-GAAP revenues for the fourth quarter of 2014 were $140.6 million, including $124.4 million in net product revenues from KALYDECO and $16.2 million from royalties and collaborative revenues.
The GAAP net loss for the fourth quarter of 2014 was $177 million, or $0.74 per share, which includes net charges of $45 million.
The non-GAAP net loss for the fourth quarter of 2014 was $132 million, or $0.55 per share, less than the expected loss of $0.65.
REVENUEWAS HIGHER THAN EPECTED.
NET LOSS WAS $.55 VS EPECTED NET LOSS OF $.65.
Those who are selling must be upset about something other than revenue or earnings report for the 4th quarter.
"That is irrelevant given the current status of Vertex waiting for the approval of the new CF combo"
Totally agree with you. However, those who trade the stock do look at such quarterly data and the PPS is sometimes affected by their action. Whether that is right or wrong action it does happen.
The US FDA requires a generic drug to "contain the same active ingredients as the innovator drug." It seems to me in order to do so generic producers could simply follow the innovator's steps to get such active ingredients. I am assuming such steps/methodologies are known and available to copy (or am I wrong?)
Any way based on what I have read on numerous times, the government of India seems to have no respect for US patents and allows companies to violet them under the guise that the typical Indian is poor and can not afford US drugs. In fact, if I recall correctly, I read that that is a one of the subjects that John Kerry plans to discuss with the prime minister of India in his next visit.
"NKTR 102 slide 13 shows that 1/10 in breast cancer are tumor free"
In addition, slide 13 shows that 10 out of 10 patients were tumor free at the 14th day and remained tumor free till the end of the data (54 days) when treated with NKTR 102+ Rucaparib. To me that is a game changer and huge.
Have not had time to listen. Any body who can give us the highlights?
Apparently the investors must not have liked what was said. Vrtx is down 2.75% whereas both NBI and BTK are in the green!
I am just wondering if Leiden said anything about moving any non-CF compounds into meaningful trials.
It wont allow any refernce to direct readers to usful information. I am trying to post info about a blog on ddd site which discusses the high speed of one of its printers. It wont let me do it. Lets see if it lets me post this critic of its actions.
"how do newer and better drugs get into the market?"
keep in mind that these new HCV drugs cure 90 to 100% of the patients. So how new HCV drugs could be better than that? so it seems to me the exclusive agreement wil lock out ABBV for a long time. Keep in mind in the rare instances that the ABBV drug does not work the patient can get Sovaldi if a doctor recommend it due to lack of cure with the ABBV drug.
As to drugs for other diseases, I suspect in any exclusive agreement if drawn properly, there will be clauses that nullify exclusivity IF and that is a big IF, a much much better drug is approved for a disease.