Replies to post #2366 on EOM Pharmaceutical Holdings Inc. (IMUC)

[erostratus]

Tonights offering was in awful timing lol...I'm not surprised though, just terrible management record over at NWBO.
They're not even done recruiting patients yet..let's see if theyre even able to keep the lights on until trial is over.

[rarefind]

NWBO screwed the longs by doing a secondary? Thats wrong in fact if they didn't raise capital after that big run they would be stupid.
Fact is if the IMUC phase 2 trial hits they won't need a phase 3

According to the accelerated approval provisions contained in both the FDA's Guidance for Industry Expedited Program for Serious Conditions - Drugs and Biologics and section 506(c) of the FD&C Act, the FDA may grant accelerated approval to:

a product for a serious or life-threatening condition . . . upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or an effect on a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.

For example, accelerated approval has been used extensively in drug development for a variety of cancers and human immunodeficiency virus (HIV) disease-diseases in which the goal of therapy is generally to improve survival or decrease morbidity and the duration of the typical disease course requires lengthy and sometimes large trials to demonstrate a clinical or survival benefit.

These documents explain in great detail the requirements necessary for accelerated approval (my comments are italicized):

Qualifying Criteria for Accelerated Approval

Serious Condition: FDA does define cancer as a serious condition
Meaningful Advantage Over Available Therapy: Current treatments are outdated and lack efficacy

Accelerated Approval Endpoints

Surrogate End Points: Not applicable
Intermediate Clinical Endpoints (clinical endpoints that can be measured earlier than an effect on irreversible morbidity or mortality): FDA expects that most demonstrations of clinical benefit would be a basis for traditional approval.

Evidentiary Criteria for Accelerated Approval

Drugs granted accelerated approval must meet the same statutory standards for safety and effectiveness as those granted traditional approval: For safety, the standard is having sufficient information to determine whether the drug is safe for use under conditions prescribed, recommended, or suggested in the proposed labeling.
Whether an Endpoint Is "Reasonably Likely to Predict" Clinical Benefit: Preventing death - extending life in a clinical trial is likely to predict the same clinical benefits

Conditions of Accelerated Approval

Promotional Materials: All this means is that promotional materials must be submitted to the Agency for consideration
Confirmatory Trials: For drugs granted accelerated approval, postmarketing confirmatory trials are generally required

Therefore, if the topline data presented upon completion of the trial is in line with expectations, accelerated approval should be granted. Considering the fact that IMUC's investor base seems to be largely composed of retail investors, this probable outcome has largely been ignored and thus the stock price is grossly undervalued.