ZERO substance to date doesn't make this a STRONG BUY............Where's the BEEF.
Wishing cancer on anyone just because their view isn't aligned with yours is just wrong. Shame on you.
Wrong board dipstick
AMEN on all points. FDA's providing a life line for another PH III trial. That's seems real nice, but it's FDA BS politics, AVEO's cash burn and need of a partnership, or game over. With an FDA 13-1 for rejection, raising cash for another PH III looks unlikely. European approval seems like the best of the choices unless AVEO secures enough money through a partnership to initiate another PH III.
I'll say it again, previous CEO, CMO / team is largely responsible for FDA rejection. They clearly botched entire review process period.
Hopefully with our new CEO & CMO, ASCO might secure a partnership, but you need to be light on long position imho.
You make some good points and I've made several here myself recently. Personally , I'm looking to reduce my position on expected upside ahead of presentation. That said, if we do start to run higher ahead of ASCO, I don't believe we find 3's again.
The company burns through cash at an alarming pace and with an FDA rejection, is going to need to raise cash very soon, or secure a partnership worthy of staying alive a few more years.
If we could obtain overseas approval, things will look much better into the massive losses here.
I continue my DD here, but have decided a large responsibility of the FDA rejection, falls on the CEO and AVEO's then CMO = Chief Medical Officer and anyone else directly involved in the material presentation to the board.
Lori Dodd an FDA panel member, indicated she found it a sloppy trial design and indicated it was to bad, as many patients will no longer have another drug treatment option.
Critics voiced their frustrations with the FDA's rejection of a drug they will no longer be made available.
As indicated in my previous post, AVEO has a new CEO and new CMO and I look forward to ASCO presentation June 1st.
and ARRAY BioPharma (CMO) Chief Medical Officer Mr. Michael Needle an expert in later-stage human trials.
NOTE: To bad AVEO didn't hire him before going to FDA for approval.
1. With Mr Needle on board since early January, I'm expecting our June 1st. ASCO presentation to go well.
2. New CEO submitted a letter of intent to EMA for European approval. EMA gave AVEO permission to submit an application for approval based on existing trial data. Keep in mind this will include all data since FDA rejection. NOTE: Many great drugs have been approved overseas that have been rejected by our corrupt FDA.
3. PRESENTATION: Tivozanib vs Sorafenib.......Tivozanib proven to be superior than approved Sorafenib.
4. FINAL results PH III trial (901) and Efficacy Results of a 2nd line TIVOZANIB Extension study (902).
5. FDA left the door open in a letter to AVEO that could include another PH III trial, but clearly AVEO will need
additional partnerships / funding.
BOTTOM LINE: AVEO's potential come back is hanging in limbo for now, but imho looks very promising.
YOU longs should look for an IPO soon.
Oh, I just farted. I wonder if the Navy will let me show them how much better my gas is?
Only validation you got is how often your wrong and how often you sit here and don't make any money, while traders make 10's of thousands of dollars daily on momentum plays.
You have yourself a really flat weekend, just like your stock lol.
So $215M burned down to $50M in a couple years with REVENUES, blows my mind. Thank God they laid off over 150 people, or this company would be bankrupt.
It's EXTREMELY difficult to raise cash following an FDA bust. That said, things better turn around soon, or this company is heading to zero.
So PRESENTATION in a week best be solid and CEO best ink a partnership soon.
Finally, the PAY of insiders is complete BS and should be reduced by 50% to include incentives based on stock performance.
REMEMBER in 2013 when FDA denied approval, many were holding shares in, or near double digits. Thereafter the stock sold off very quickly trapping many shareholders unwilling to bail, while many others clearly dumped as the stock sold off huge.
I suspect many shareholders who decided to ride it out, may have sold into the most recent run. Others bought into the 94 MILLION volume pop and are holding ahead of next catalysts coming very soon.
New CEO and new chief scientist will provide a top notch presentation and very likely ink a new partnership.
Exciting as we head into PRESENTATION in a week :-)
Ummm, didn't mean FDA approval abroad lol.
Partnerships can come with all sorts of terms. It's likely AVEO moves forward with an international partner as AVEO has indicated they are looking for FDA approval abroad.
I suspect some expenses could be 50/50 as AVEO has don't with past partnerships. This will further preserve cash, allowing AVEO to continue work on pipeline while also preparing another attempt on failed FDA drug.
CEO has indicated they are seeking partnerships and left the door open for a buyout. New CEO and other new blood at the company, bring a boatload of experience on preparing for FDA approvals.
The stock remains undervalued if you fully understand the BS the FDA used to deny approval.
When approved drugs failed extend life, AVEO's drug was used and here lays the FDA rejection BS. As the patience continued to near death on approved drugs, AVEO's drug was seen as a final death sentence.
FDA basically said AVEO's drug increased deaths, when the fact remains to this day, AVEO's drug has proven it's better than drugs used before theirs. When AVO's drug is initiated, it's proven patience whom remain on drug, are still alive today many years later.
AVEO's drug would have been approved, had it refused to follow failed approved drugs in patience that were worsening. Those deaths should've never been counted against AVEO by FDA.
Trust me, many great drugs don't get approved. A boat load of politics are involved costing people their lives.
FDA is BS in so many cases and AVEO will prevail.
performance after 2013 rejection has taken notice of investors once again. Once a BILLION DOLLAR market cap, 300 employees and over $350M invested by investors, i look forward to the presentation later this month.
Investors were able to see the unfairness by the FDA's rejection and how it came to it's decision. With some new blood at the helm to include additional drugs in the pipeline and updates coming, hang on to your shares.
AVEO will likely announce new partnerships soon.
How about another zero substance presentation ending in more losses and no SIGNIFICANT money orders.
What's wrong with this picture?
Don't worry about this going down. Just look to average down ahead of upcoming presentation. Should hear an announcement of a new partnership thereafter.