You are probably right. Only some Institutions get it. The others will soon get it.
1135 alone = ALexion
RIndo and Glemba = Regeneron
Varli = Celg
Add all others and the grand total looks like Gilead.
The fastest I have developed an NDA with my colleagues is 4-5 months which means, they are already prepping it right now. I would guess that the FDA would request interim ACT IV data with the full recurrent data, knowing that approval of recurrent would only lead to off label use for front line.
I believe RIndo has priority review, so a submission by May/June will lead to a PDUFA in December.
One such target in GBM is the mutated epidermal growth factor receptor variant III (EGFRvIII), which is a tumor-specific epitope expressed on approximately 20%–30% of GBMs, 78% of breast carcinomas, 73% of ovarian carcinomas, 42% of head and neck squamous cell carcinomas, and 39% of non-small-cell lung cancers.
Rindo will be a blockbuster. $100/share
Glemba - GPNMB prevalence is much higher than expected...this will be a blockbuster. $300/share
Varli - $8 billion per year. $800/share. Any positive results will trigger an acquisition by BMS.
All other drugs in the pipeline - potential blockbuster.
With a Rindo approval, we will generate enough cash to fund the entire pipeline which includes moving 1135 forward. 1135 will exceed Alexion alone, another blockbuster
Roche should just buy out CLDX for $10 billion and get it over with.
Roche is losing Avastin (Rindo) and Herceptin (Glemba) patents and need to combo their anti-PD1 with 1127. Then combo everything else in CLDX pipeline to Roche's.
But we both know its probably going to be BMS. Notice how Pfizer is willing to pay billions to partner with Merck on one drug. I believe its $850 million up front. 1127 has the same potential as the entire PD-1 market.
$36+ and yes. Stock price should not have dropped below $25 with 2 drugs in pivotal/confirmatory trials. I have seen many results over the years. One does not usually see results that are clearly positive.
That is based on first indication. Many did not think this would work on recurrent let alone a vaccine for GBM.
Stock price did not really include Rindo. Now it will be fully reflected. We can add $2 billion to the market cap. Investors buying in with shorts covering... the next 2 weeks will be epic.
I am in the same camp with LongVrts. The news will be positive. 110 and 011 both have a high probability of approval. The real question is when.
Lets bring the una back so we convert all phase 3s to phase 2s again.
We would have a drug on the market right now generating 500 million per year.
Dec 15 - 110 nda
Dec 17 - 011 nda
2 year spread between launches much more realistic
Looks like Glemba study will include both high and moderate GPNMB...expansion of the pt population which necessitated dropping ORR but they felt PFS will still be adequate for global approval. They probably already know this to be the case. They sacrificed one year now to reduce time and cost of running other studies in the future.
I am still puzzled to why there was no CC tied to negative news. If they knew the price would dump, what exactly do they have on November 14th to compensate for today?
Financially, we knew the cash burn would be high.....one of the reasons for dropping 1135 for now. Operationally, the human resources are under significant strain...another reason for dropping 1135 for now.
Marketing and Sales wise, I never thought that they could launch two drugs simultaneously.
Lets see what happens on the 14th.
Saw that as well. If the investgators and pts did not see clear benefit, then there is no compassionate use.
Its a struggle to find something sufficiently positive for the gatekeepers to accept.
Just personal experiences.
Just the fact that the conference accepted the abstract means the results are positive which only reinforces the notion that ACT IV and eventual approval becomes only more likely. Price with P/S of 8 will eventually reach $100 per share.
The real question is how good is it. If the results are good enough for early approval, then a triple will occur overnight.
We had a perfect storm to bring this down. Institutions just played into it reach their 92%.
The perfect storm to bring this up has formed.
Institutions maxed out and released the breaks
IBB settled for the past 12 months and is now ready for growth again.
Positive expectations on full React results.