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Expecting all time high shareprice by end of the month.
Still holding my shares through data releases.
Too many fail p3
And yet therin lies the caveat: too many datamining of p2 results in the hopes of finding something worthy of taking into p3. I whish the FDA would be more strict. It would help pharmaceuticals in the long run of avoiding futile p3's. Eg all the amyloid plaque based Alzheimer trials recently.
Ofcourse as an investor I hope our p3 will be able to replicate the results. But I do not take my whishes for reality. Too many fail this very crucial test. (Which makes sense or else why have a p3 if it always is successfull)
Replicating results in a p3 with larger n-pool is not a piece of cake. I do not assume that by default it will be a success. Too many fail here.
Sounds like its a piece of cake:
all you need to do is to replicate the dosing regiment of those 6 in phase 3 and get the same results.
As per dr Wilson this week, enrollment would start any day
DOD funds the 280 patient trial
Why waist a pr on a Friday? Keep it till Monday
Doubt it very much. Usually this is done as the cheapest way to get listed.
"Decided early not to do an IPO"
Seriously you need to do your DD. The founding history and the buying of a printing company to get use it as a shell to list on the OTC, has been Well documentend
It was first reported in an Anavex Facebook group
I would think a boring year, awaiting results. Any expected this year?
Nice to report in today's investment presentation. Don't forget to listen at 9am pacific time
https://event.webcasts.com/starthere.jsp?ei=1130636
Nice summary!
Presentation of BIIB is up and all about haemophilia.
There was a comparison made according to market cap, which is unfair. Comparing to premium makes more sense to me. Hence 7.05, which would make me unhappy if this was the price paid for Anavex.
I would consider $7 still undervalued!
A 75% premium was paid. Anavex equivalent of $7.05
I would not be happy!
Whatever personal ethical views one may hold, it will be the FDA deciding. And as they require placebo with cancer drugs I can imagine the same will apply with Alzheimer.
I would be happy with funding to start the p2/3
Read the whole post and read it with irony-glasses
To believe we will obtain FDA approval on this non-optimized trial with primary endpoints of safety and max tolerable dose and a trial population of 32, is not realistic.
Compared to the experts, I am sure both Missling and McFarlane are unknowledgeable as they keep talking about working with the FDA on trial design and having a p2/p3 trial with n=300 and double-blinded, placebo control arm.
Sorry but one cannot compare a rare disease with Alzheimer.
You are barking at the wrong tree. Focus on convincing the FDA
But given the small patient population there is always this chance that the current trial participants are not representative of the broader population.
They could... but really based on a p2a with an n=32 ?
Don't think so. Would not make sense to simultaneously help Anavex in the p2/3 trial design.
Sweat: Yes
Stupid to communicate that: Yes
Can you imagine the lawsuits?? We just got rid of them.
AXON drug failed multiple p3 trials at GSK, thats why they sold it for peanuts. No idea why the market expects a different outcome this time.
Soligenix Receives Positive Scientific Advice from the European Medicines Agency for SGX942 in the Treatment of Oral Mucositis in Head and Neck Cancer Patients
PRINCETON, N.J., Jan. 5, 2017 /PRNewswire/ -- Soligenix, Inc. (SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the company had received positive Scientific Advice from the European Medicines Agency (EMA) for the development of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy. The Scientific Advice from the EMA indicates that a single, double-blind, placebo-controlled, multinational, Phase 3 pivotal study (IDR-OM-02), if successful, in conjunction with the Phase 2 dose-ranging study IDR-OM-01, is generally considered sufficient to support a marketing authorization application (MAA) to the EMA for potential licensure in Europe. The advice also provides several constructive suggestions to strengthen the study design and data collection that will be integrated into the final protocol.
"We are pleased that the EMA agrees that the proposed Phase 3 clinical study, if positive, is sufficient to establish the efficacy of SGX942 and support an MAA filing," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We believe that this positive Scientific Advice outcome represents a significant step forward in our oral mucositis development program and has the potential to accelerate the registration timetable in Europe. We look forward to incorporating the EMA's protocol suggestions with those from the US Food and Drug Administration. Given the current timeline, we anticipate initiating this pivotal Phase 3 clinical trial in the first half of 2017."
I know just the company for his plans :)
You describe the basics of risk management. I am sure that the acquisition or partnership departments of big pharma are aware of the catch22. Perhaps they had one too many failure and want to see more data before committing?
If Anavex really has the stuff, and the necessary patents, then the price difference will not be too important given the revenue potential.
According to AF the AXON p3 data is one to look forward too... no clue
https://www.thestreet.com/story/13939672/1/17-thoughts-on-biotech-stocks-to-kick-off-2017.html
True, so we now know of at least 2 public events in Q-1 that Anavex is participating in. Keep'm coming
Thanks but obviously on a different level then the JPM one
Will Anavex be attending the JP Morgan health conference in San Francisco? Nice venue to announce deals!
No objection blu. But to therefore conclude that our p3 will be a slam dunk is taking it too far. I always advocate to keep it realistic
Many many many p3 failures were p2 successes. Caution is always healthy. As dr MacFarlane advises in the interview
Would you equal early 2017 with Q1?
That is your opinion. If I were Missling I would keep my cards close to my chest, especially with such a loose lipped McFarlane.