I don't think we can conclude the FDA has sent a letter, can we?
It says " the Food and Drug Administration ("FDA"), has notified the Company that the agency will provide comments on RCP's Investigational New Drug ("IND") application."
The IND overview of the process that crooked_analyst has posted indicates phone calls are another likely source of contact. In fact, it says be ready to receive an unannounced phone call.
In any event, whether a phone call or letter, it appears RCP may not even know what the specific topics are the FDA wants to discuss given the following statement from the press release.
"When we receive the agency's official comments and/or recommendations...."
"When we receive" implies to me that RCP may not even know the specific topics yet, doesn't it?
If the IND was submitted at the end of June, about the same time as the SEC filing was made, then that would put the process at the start of the 3 to 4 week. According to the above, that would be about the time when questions and specific requests might come from the project manager.
I agree that the wording is important.
Note this wording also - "When we receive the agency's official comments and/or recommendations..."
That sounds like the FDA may have questions or comments on the way the Phase 1 trial is to be conducted moving forward.
“Rock Creek Pharmaceuticals, a publicly traded firm working to develop medications for inflammatory conditions and neurological disorders, is relocating its headquarters to Manatee County's Roskamp Institute…”
“The Bradenton EDC assisted the Glen Allen, VA based pharmaceutical firm in applying for rapid response permitting to facilitate the move into the 3,000-square-foot space at the Roskamp Institute in Tallevast in south Manatee County. Rock Creek also received a performance-based grant of $48,000 from the Manatee County government to help fund its relocation. To qualify for the incentive, Rock Creek has agreed to create 16 high-impact jobs over the next five years that provide an average wage that is twice the Manatee County annual average.”
"If we're successful, we have the potential to grow a lot bigger. I think a 16 employee count is a conservative number,'' Jenkins adds.
Google - Virginia Pharmaceutical Company Moves Into Roskamp Institute In Florida
To read the entire article
I don't think that Investor Presentation which was filed in the 8k was meant to target retail investors, do you?
Time release and dosage are major differences imo. For example, Aleve and Naproxen are essentially the same thing. Aleve is sold over the counter in lower dosages while Naproxen is still prescribed in higher dosages.
In regards to isomer differences, I don't understand all that stuff but it makes sense that could also be another major difference. For example, isn't Nexium a different isomer version from Prilosec?
I think Prilosec can be purchased in lower dosages over the counter?
"Attached as Exhibit 99.1 to this Current Report on Form 8-K is an investor presentation, which Rock Creek Pharmaceuticals, Inc. may use in presentations to investors from time to time."
So does this mean RCPI has plans to go out and make presentations to new investors using what was filed?
I am guessing it does. No wonder all the shorts are out in force today.
"And what will distinguish the neutraceutical from the prescription version being contemplated from a science perspective?"
my guess, time release and dosage level as a start
I think you miss the point.
Prevagen is being advertised after having received an FDA warning letter.
What I heard was obviously a paid commercial.
Now this is interesting, according to a published article (Google - The FDA looks into Quincy Bioscience's claims for Prevagen), Quincy received an FDA warning letter back in 2012.
"On Oct. 16, 2012, the FDA issued a warning letter, stating that Quincy was selling "unapproved new drugs" -- and not dietary supplements -- based on the unverified health claims on its website and Facebook page of "miraculous" cures of memory loss, including from Alzheimer's and dementia. The FDA further alleged that Quincy failed to report more than 1,000 "adverse events" among Prevagen users, including some that required hospitalization."
"When asked about the FDA's assertion that Quincy "failed to report serious adverse events...like seizures, strokes and worsening symptoms of multiple sclerosis that had been reported to your firm as being associated with the use of Prevagen products," Underwood admits "we needed to sharpen our paperwork" on recording complaints. But he says serious problems only numbered about a dozen and argues they weren't evidence of a problem with Prevagen. "We sell a product to an elderly population, and they do have strokes. They do have issues," he says. "But we don't have evidence in any of those cases that our product is causative.""
The article also goes on to say
"Quincy Bioscience, the fast-growing Madison brain supplement maker, has all but settled its problems with the federal Food and Drug Administration, says Quincy president Mark Underwood. "To make a long story short, we're in a fine place with the FDA," says Underwood. "We've been able to satisfy all of their requests.""
"Today, Prevagen is available at more than 20,000 retail locations, including Walgreen's and CVS drugstores, and it's sold online as well. Inc. magazine says Quincy's annual revenue has grown 234% from 2009 to 2012 -- from $5.3 million to $17.8 million."
Well, well, isn't that interesting?
Merck will buy Idenix Pharmaceuticals for $3.85 billion, bolstering its ability to compete in the growing market for hepatitis C drugs, the companies said Monday.......
An estimated 3 million people in the USA are chronically infected with hepatitis C, the nation's leading cause of liver cancer and liver transplants. About half or more of those with hepatitis C don't know they have it.
Idenix had a net loss of $122.3 million on revenue of $500,000 last year.