I don't hate stocks, I don't love stocks, but above all I do not fool myself.
It reminds me of the Otrerxup discussion - no arguments, just personal attacks.
At that time I also posted some thoughts, analysts and personal discussion with doctors.
Somebody, like you, said that I am making that up. It turned out that my predictions were more accurate.
That''s my personal opinion, backed by some research. If you do not like it, so it be.
Save my post and let's revisit it after the Q4 CC.
I do predict Teva will report 50-60M for Gx Epi. So let's see how far I will be from that number, shell we?
I was intrigued to see what is actually interesting - some new info or so.
It turned out to be that you are "just confused". But everybody on the board knows that, not a big surprise.
Here is what some less confused analysts expect from the Epi launch
- 10-20% in 2015
- 30-40% in 2016
- may reach 50% by 2019
- end of life 2020 (a bunch of competitors enter the market)
Main reason why Epi is different from other generic drugs
- Epi is a life saving drug. many would not want to mess up with something new
- Epi is more like an insurance - you buy it and in most of the cases do not use it, until it has to be replaced a year later
- Many customers will request the brand, regardless of the pharmacists trying to dispense AB rated drug
- Many will just pay the difference b/n specialty generic (tier 2) and brand (tier 3) - about 30 dollars per year (depending on the plan). It is not a big deal and many can afford it
- MYL has a web of contracts with large customers like Disney, school districts, ER providers and such
- MYL has multi-year replacement program with many of his large customers
- a mini- survey of a family we know singe ages, who had a boy with severe allergy, indicate that they categorically reject any idea of buying not the brand product. As my friend responded with anger on my question about Gx Epi -
"I do not put the life of my boy at risk for a cheap generic, period. If something happen, i will hate myself for the rest of my life that I put at risk my boy for a miserable saving of 30 dollars per year"
It is hard not to agree with him, right?
While we here theorize how much money we can make from the poor kids with severe allergies, the parents don't buy it. Some of them have been already through the horror of anaphylaxis reaction and know that they can relay on the brand Epi. They do not care if the generic is AB or ABCDEFGHXYZ rated. For them it is just cheap generic. It is a perception which will be hard to overcome.
fDeal Professor By STEVEN DAVIDOFF SOLOMON
A Netherlands company can issue preferred shares to a foundation known as a stichting. The foundation can then exercise these shares to take voting control over the company if the foundation determines it is in the best interests of that company and necessary to maintain the status quo or to explore alternatives. However, the foundation’s voting control is only temporary.
But the maneuver has some drawbacks. First, it is very heavy-handed. Instead of the array of defenses and tactics Mylan would have in the United States, it instead has been left with only a “nuclear” option. It also has been used only a few times, and even in KPN’s situation, the foundation took the position that its actions were temporary to try to buy “peace” until a price could be negotiated. Moreover, if the foundation does act, Mylan’s mostly American shareholders will be unhappy because of the loss of voting control over Mylan.
Even worse, a stichting is notoriously independent and because of this was used as a legal structure to protect assets from the Nazis, among other things. Accordingly, Mylan has no legal control over this foundation, meaning it can act even if Mylan does not want it to. In other words, Mylan has no control over its big defense. Its fate is in the hands of an independent third party.
Dr. Donald Sanders did not say that this is the study to apply for NDA.
He knows well that it is s single arm open label by "invitation only" trail, no compactor arm, no specified end points. Probably he thinks that the results justify starting real Ph 3 registration trail double blind, placebo controlled.
Check it - Jacobus NCT02090725 and compare it to Catalyst NCT01377922
It is naive to believe that such data can be used for approval.
I am sure AF knows that also very well, but he will use any single opportunity to go after CPRX.
Today article is pure journalistic travesty.
But at the end of the day it does not matter He can create a temporal turbulence, that's all.
Jacobus NCT02012933 is compassionate program - not a registration trail
Jacobus NCT02090725 is single arm open label by "invitation only" trail, no compactor arm, no specified end points. Age restriction: 45-65
Catalyst NCT01377922 is double blind, placebo controlled, each pts is self comparator (Firdapse during a 91 day run-in period followed by either Firdapse or placebo randomized 1:1 during a 2 week randomization period), Age 18 and older.
I do not know any single arm, open label trial use as registration for NDA. It is unprofessional to compare these two trials and it is naive to believe that Jacobus had any chance with FDA
I am sure Adam F knows that very well, so the article today is journalistic travesty.
Jacobus NCT02012933 is compassionate program - not registration trail
Jacobus NCT02090725 is single arm open label by "invitation only" trail, no compactor arm, no specified end points. age restriction - 45-65
Catalyst NCT01377922 is double blind, placebo controlled, each pts is self comparator (Firdapse during a 91 day run-in period followed by either Firdapse or placebo randomized 1:1 during a 2 week randomization period),
Age 18 and older.
So they did run-in period, what whogo is talking about, and the trail is completed. They reported top line data Sep 2014. Now they are preparing the NDA.
I do not know any single arm, open label trial use as registration for NDA.
It is unprofessional to compare these two trials and it is naive to believe that Jacobus had any chance with FDA
I am sure Adam F knows that very well, but enjoys being sadistic. Many think that he is corrupt and coordinate your articles with short hedge funds. I do not believe that, because he can end up in jail. I think that he is simply naturally very bad, mean-spirited person.
Whogo, do you have a link to this information about Jacobus progress?
Any communication with FDA?
It is very difficult to believe that FDA will entertain NDA from Jacobus. They have run a trial with invitation only without protocol. Their facility is below modern standard for drug production. Based on that I believe their NDA process will last forever with a high probability for rejection due to production and protocol non-compliance.
CPRX completed the Ph 3 in Sep 2014, had a preNDA in February and are submitting the NDA in 3Q15. With BTD their approval process will be much shorter. And finally the drug is stable.
Even if Jacobus submits first, CPRX has better chance to be approved first bc they did everything what FDA asked them.
To see the difference in the quality of CPRX data compared to Jacobus - CPRX had a oral presentation in the Plenary session, while Jacobus had a poster.
My experience giving many talks on a number of conferences is that
- standard data go to poster session, nobody pays attention - 1000s of posters in a crowded room
- good data go the oral presentation, good size room (100-200 seats)
- very good data with significant impact on the progress in any particular field go to plenary session - huge auditorium .1000 seats. Having a talk in the plenary session is a sort of gold standard.
BTW, today one of the directors took advantage of the price drop and got 5k shares
the cap of the company jumped form 91M (yesterday close) to 118 (today 6.7 pps) - i. e 28% jump.
My observations are that the stocks tend to revisit their market cap before the secondary.
Not all, but most of them do. For example ESPR did a 10% secondary at 100, in a week or so dropped below 90 - exactly revisiting its old market cap. Since then it recovered and now trades at 108.
I do not have a position but may buy some shares below 5.50, if it ever gets there.
yes, I still have my shares. It was unfortunately a big blow. The main problem is not about meeting primary end points, as reported, but losing efficiency over time.
I had a protection - June $20 put at $2. However it only covers my initial investment - my average price was $18. Unfortunately all profits are gone.
But I am mainly disappointed because it was such simple case like ESPR - first new drug in decades, potential 2B revenue, clear BO candidate. All that is probably gone, or at least delayed for years.
About CLVS - what offering at $4 you are talking about?
Deerfield with 7M shares will become the biggest holder. So far Palo Alto was on the top with 2M shares.
aeri just published disappointing ph 3 data ::((
I am surprised since the ph 2 data were very good.
They still have a second Phase III, but this is definitively a set-back
BO adds about 50% premium to $4 PT. Without BO the PT for the following years is:
$4; $5; $6.40; $7.80 and $10.00 by 2020
Again, Otrexup partnership could add $1 to all of the above.
QSM significant progress could add another $1 or even 2
PT for 2018 depends from many factors, but realistically it can be as high as $6 to $6.50.
If we find a partner for Otrexup - about $1 higher.
If we make a good progress in QSM - another $1 higher.
Oh, I see.
If you know how FDA works, needle free is at least 4-5 years down the road.
It will not add to the PT even a cent, but it is great to talk about anyway,
Probably the same, only the probability would increase, if Teva wants to consolidate the injectable business across the new, much bigger company.
BTW, what is NFQST? I do not recall we are doing any clinical trial for that.
No, it is not exactly true. I said partnership, but BO is not excluded.
In case of BO the target price is $6, base on projected $4 PT plus 50% premium.
OK, since it is OT, let me add another name here - KYTH.
They expect PDUFA on May 13. The ADCOM was hugely positive - 13 to 0.
Looks low risk PDUFA play and beyond - aesthetic medicine market is big and the mgmt is strong.