when this offering becomes effective, Oncs can sell shares. 75 million at $1 ? Giving them 300 million S/O before the 1 for 10 reverse split this fall ? I feel better now, I can be called an idiot like all the fools saying "this is great news" ! "hurray" ! "huge dilution, yippee" ! " Dilution, bigtime. CEO is killing upside.
Approximate date of commencement of proposed sale to the public: From time to time, after the effective date of this Registration Statement.
The FDA speaks of a confirmatory ph IV to be conducted after AA, if efficacy shown after a ph II trial is somewhere in the order of p = 0.0001 , a decision to give full approval is not out of the question.
The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.
Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. These studies are known as phase 4 confirmatory trials. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.
Joe, DO NOT NEGOTIATE with any company until the FDA approves or denies the nda for the generic version of midodrine. We know the trial was completed recently and I'm sure you're aware of the leverage you will have to close an excellent deal for shareholders. - respectfully, the Weasl (lol)
our poor little doggie Chtp, abandoned to the pound, nobody (BP) wants to provide a home. ___________________________________________________________
Chtp put out a p.r. last month, 3/15, with quarterly and year end earnings. No c.c. - I suppose they could do the same this month, Zzzzzzz. - One can only hope Joe has "sources", would be nice if he can get his hands on a copy the midodrine trial results. Wave the failure in front of Biogen execs ? Lol. A partnership or BO will be a completely separate event from the 1st quarter earnings release. I think deal making is over till we see the FDA decision on that NDA for Proamatine. (sic)
this is the trial the FDA will base decision on. - approve or remove generic midodrine
About Clinical Studies
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Study Record Detail
Trial record 1 of 1 for: NCT01515865
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Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension
This study has been completed.
Information provided by (Responsible Party):
First received: January 18, 2012
Last updated: April 7, 2014
Last verified: April 2014
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To study the effect of midodrine against the symptoms of orthostatic hypotension
Symptomatic Orthostatic Hypotension
Drug: Midodrine HCl
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 4, Randomized-withdrawal, Double-blind, Placebo Controlled, Parallel-group Study to Investigate the Clinical Benefit of Midodrine Hydrochloride in Male and Female Subjects With Symptomatic Orthostatic Hypotension
Resource links provided by NLM:
MedlinePlus related topics: Fainting Low Blood Pressure
Drug Information available for: Midodrine hydrochloride
U.S. FDA Resources
Further study details as provided by Shire:
Primary Outcome Measures: •Score on OHSA rating scale [ Time Frame: 30 minutes post-dose on Day 16 ] [ Designated as safety issue: No ]
•Syncope/Near Syncope within 15 minutes of standing [ Time Frame: 30 minutes post-dose on Day 16 ] [ Designated as safety issue: No ]
Study Start Date: May 2012
Study Completion Date: November 2013
mark87now, read your post and the lightbulb is on ! Yesterday's update: This study has been completed - ..could this mean the results are in, the FDA review is April ? Speculation, one of my best attributes LOL .Glta, Joe superman, holding out till results amidst all the mockery ; )
February 8, 2012
FDA’s Center for Drug Evaluation and Research (CDER) and Shire have come to an agreement for Shire to conduct two additional clinical trials to verify the clinical benefit of the drug ProAmatine (midodrine HCL). While these trials are taking place, CDER’s proposal to withdraw approval of midodrine has been put on hold.
Should CDER determine that Shire has failed to adhere to the terms and timeframes in the joint agreement, as outlined in a December 2, 2011 letter1 to Commissioner of Food and Drugs, Margaret A. Hamburg, M.D., or that the clinical trial results fail to verify the drug’s clinical benefit, Shire has agreed to have FDA withdraw approval of the New Drug Application for ProAmatine and to waive its opportunity for a hearing.
if data is a bust, we're going to love our doggie Chtp : )
-The replies have made this a valid thread. Thanks
- We have our work cut out for us. "Under no obligation to post results publicly" ...I must be honest, I have done NO dd on the shire drug. Could they have outstanding results ? We must be objective . Do not allow our $$ in Chtp to skew our analysis of the Shire trial. IF we can find it. I estimate 2 months minimum from trial end to data release........ok, forget all that. The FDA will make a decision, I guess. ? Sorry about the babble, the remove feature will be in play tomorrow.
FDA site, a quick glance of Midodrine history with them.
fda (dot) gov/........Drug/.........DrugSafe ------ remove the dots -
bb44, - I enjoyed your reply. - I'll stand by my "new melanoma trial" ie: new dosage, new timetable - Data used towards ph III design will not incorporate the lower dose result.
- "trial that is currently producing the best in class data" - Who said this and where can I find it, thanks.
- "relaunch (are) occurring because their data is that good" - I'm not aware of published data for the T cell Lymphoma trial, you've seen it ? Link.
The gentleman jbem777......It's nice to see an intelligent, educated investor in Oncs. - "a faster conclusion to the study than originally planned." An excellent explanation justifying the term relaunch. Reading his post, at no time did he say EP/IL must be working. The jump from new parameters in the trial to -showing efficacy- cannot be made. Not yet. end of discussion , lol ! : )
lady.domina2 - you are an astute investor and you are correct. The melanoma trial, 9 months after full enrollment Oncs announces "21 new patients to be enrolled at a higher dosage and increased dosing frequency" - It should be obvious to investors, Oncs has not found the MTD, essentially starting a new melanoma trial, the only reason to change dosage is to improve on existing trial results. - The re-launch of T cell lymphoma trial, same thing - .....got to go, back tonight, with examples of failed ph II trials, data mining used to announce "moving on to ph III" .
.....sorry to clutter the board with messages .....but my reasons to guess Melanoma - The ph II trial had full enrollment last June per the Oncs p.r. , open label, I believe 25 patients. The data generated by this trial should be near conclusive, something I believe ASCO prefers. We've all seen the DSMC give the green light on safety and efficacy looking at interim trial results, only to see missed primary endpoint (fail) at trial conclusion. The MCC trial, planned enrollment of 15 patients, began in 2011. Three years later still enrolling, well till now. I would prefer an MCC abstract at ASCO. April 21st our speculation will end, if abstract not accepted, I hope Oncs will make available on their site.
With all due respect to everyone on Ihub, It's nice to see the CONFIRMATION of my earlier posts.
- Dr. Adil Daud, M.D., oncologist, melanoma specialist- with his expertise in the melanoma field, Dr. Daud's experience puts him in a position of high demand. . . .. . . . . .. . .
- With respect to his AACR schedule this weekend. Those presentations have no correlation to Oncosec Medical. _______________ 4/4/14, Friday afternoon.
- Reading the abstract title, looks to be a Merck abstract,..there will be no p.r. from Oncosec ....... no connection whatsoever. ______________ 4/5/14, Sat., 10am
call it an educated guess, lol , the asco abstract submission, melanoma ph II.
I guess we'll know more Sun. afternoon. - Reading the abstract title, looks to be a Merck abstract, their anti PD-1 drug, MK-3475. , in a melanoma trial. .....There will be no p.r. from Oncosec Medical - nada, zip, zero, no connection whatsoever. Clinical trials have not begun using Oncs EP/IL-12 and anti PD-1 drugs. Stay tuned. : )
craigakess - all those thumbs down, lol, it's your refusal to wear rose colored glasses ! I like your post............keeping it real time and time again. thanks.
jepetersonus, I appreciate it when an investor is willing to do some serious research into an equity they hold. That being said, I hope you're not adverse to an opposing opinion : )
Dr. Adil Daud, M.D., oncologist, melanoma specialist. - With his expertise in the melanoma field, Dr. Daud's experience puts him in a position of high demand. Lead investigator for the melanoma trial gives the Oncs EP/IL-12 technology an increased 'credibility', for lack of a better word.
With respect to his AACR schedule this weekend. Those presentations have no correlation to Oncosec Medical. Yes, a partnership with Merck does seem likely especially with the addition of Dr. Pierce, personally I hope Merck is willing to sign on with Oncs by summer, after a thorough review of data/abstracts that should be released in May. The MCC paper.
Who completely understands the post below and can explain the argument for failure.
kahn_boonie • 6 hours ago Flag
ONCS is a sham, or in another word, an imitation. INO's approach is potentially revolutionary, but fraught with risks. INO's choice to deliver plasmids as vaccines has a hell of a lot better probability of success to elicit sufficient immune response. One of the biggest questions is whether electroporation will enable sufficient delivery of these plasmids (i.e. will doses be delivered high enough) in sufficient quantities to elicit adequate T cell response. As I understand it, INO is not delivery milligrams of these plasmids, as that would be prohibitively expensive. Delivering chemotherapeutical agents, which is what ONCS has licensed the electroporation technology to do from INO, will require nanomolar concentrations to be achieved within the target cells. That will be orders of magnitude more "actives" required to be delivered. Which one are you willing to bet on, a manned mission to Mars (INO) or a manned mission to Alpha Centauri (ONCS)? You can certainly bet on both; but which one do you think has a better probability of success? Less
cribbed from the chtp board.
the weasl stuck his nose under the big tent, did a TON of reading too. by hook or by #$%$ shares will be had. with the existing float, Igxt can easily carry a higher price per share. GLTA