---There was/is a QA between Regen the FDA (pret
Post# of 5066
Posted On: 09/11/2013 11:19:17 AM
---There was/is a Q&A between Regen & the FDA (pretty typical. Especially for start-ups)
---During this Q&A the company provided additional efficacy data at the request of the FDA
---Why was the company contacted by the FDA after submission of the IND application? Was it because they found serious issues with the treatment? Most likely not since they (Regen) would have been informed via telephone and in a very detailed letter that there is a partial or complete hold on the proposed treatment for XYZ reasons. Such a hold would have to be disclosed by the company, would it not? Is this not considered a material event? Is such a material event not required by law to be disclosed to the shareholders?
---The "delay" or "Q&A" as it has been announced by the company could have very well been created as a result of simple information on the cover letter or included material, not matching the information on the application. Simple mistakes made during the process by anyone faced with the daunting task of working with a governmental agency. These mistakes (such as details for the lead investigator, mock label details, unacceptable design of the efficacy data {although the data is 100% acceptable} etc., etc.), though relatively simple to correct do cause delays in the processing of the application. It IS the government they are dealing with.
---Regen would have been advised that they must await confirmation by whomever is in charge of the application before they can proceed.
---There are a number of mandates invoked beyond covering the safety of patients for investigators. One simple issue can cause a "delay". Ergo, a "Q&A".
---If the FDA informed Regen that they found cause to deny the trials or that a clinical hold is placed due to a plethora of safety or efficacy issues thereby subjecting the application to a long term delay, would we not have received notice of this since such a material event must be disclosed?
Again, we do not know what prompted the Q&A. We have no idea what the "delay" is caused by. We do know however, that the we have not been advised by BMSN/Regen that there is anything but some questions being answered. We also know that the treatment has recently been indexed in the FDA system. We also know that the treatment is very much of interest to various organizations, particularly those presently looking for AA cures. And we know that the company has done a great deal of clean up and is looking better and better on paper so that when those new investors jump on board, there will be no questions about where the company is heading and how they plan to get there.
Anyone who says otherwise is full of it.
BMSN
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